PlainRecalls

Terumo Cardiovascular Systems Corporation

Compiled from official public sources by the publisher.

204 recalls on record · Latest: Jul 2, 2025

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Agency notice ledger

Federal filing book Terumo Cardiovascular Syste… HEAVY-BOOK · SINGLE-AGENCY

#69 of 14,151 · 204 notices · 0.195% archive

  • BOOK 204 notices
  • RANK #69 of 14,151
  • SHARE 0.195% archive
  • AGENCY FDA Devices (204)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 2, 2025
  • PHOTO Teleflex Medical

Nearest notice-volume peer: Teleflex Medical (0 notice gap)

Terumo Cardiovascular Systems Corporation accounts for about 0.195% of the 104,423-notice archive on 204 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Terumo Cardiovascular Syste…'s standing among 14,151 recalling firms

Terumo Cardiovascular Systems Corporation ranks 69th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Terumo Cardiovascular Syste… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

204 69th of 14151 higher than 14,082 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Terumo Cardiovascular Syste… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Terumo Cardiovascular Systems Corporation holds about 0.195% of archive notices alongside 204 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jul 2, 2025

CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
FDA Devices Moderate Apr 9, 2025

Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Devices Moderate Apr 10, 2024

Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534 75607 75765 75797 75833 75903 75956 75973 76131 76178 76278 76306 76398 76427 76498 76519 76536 76565 76575 76628 76630 76635 76644 76687 76725 76775 76789 76832 76839 76878 76900 76999 770
FDA Devices Moderate Apr 12, 2023

CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
FDA Devices Moderate Apr 12, 2023

CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
FDA Devices Moderate Apr 12, 2023

CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
FDA Devices Moderate Sep 1, 2021

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
FDA Devices Moderate Jun 9, 2021

The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number:

FDA Devices Moderate Jun 9, 2021

The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415
FDA Devices Moderate Jun 9, 2021

The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to

FDA Devices Moderate Apr 14, 2021

Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
FDA Devices Moderate Dec 23, 2020

(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.
FDA Devices Moderate Sep 23, 2020

Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
FDA Devices Moderate Sep 23, 2020

Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
FDA Devices Moderate Sep 23, 2020

Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
FDA Devices Moderate Feb 19, 2020

Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos in
FDA Devices Moderate Feb 19, 2020

Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos

FDA Devices Moderate Feb 19, 2020

Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arteria
FDA Devices Moderate Feb 19, 2020

Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos

FDA Devices Moderate Aug 7, 2019

Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
FDA Devices Moderate Aug 7, 2019

Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
FDA Devices Moderate Aug 7, 2019

Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
FDA Devices Moderate Aug 7, 2019

Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
FDA Devices Moderate Jun 19, 2019

Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
FDA Devices Moderate May 22, 2019

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
FDA Devices Moderate Mar 6, 2019

Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
FDA Devices Moderate Oct 31, 2018

VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surge1y for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requit¿ing blunt dissection of tissue including dissection
FDA Devices Moderate Oct 24, 2018

Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
FDA Devices Moderate Oct 3, 2018

Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
FDA Devices Moderate Oct 3, 2018

Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
FDA Devices Moderate Aug 22, 2018

CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For docum
FDA Devices Moderate Aug 22, 2018

Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters
FDA Devices Moderate May 2, 2018

Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
FDA Devices Moderate Apr 25, 2018

Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
FDA Devices Moderate Apr 25, 2018

Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
FDA Devices Moderate Apr 25, 2018

Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
FDA Devices Moderate Dec 27, 2017

TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
FDA Devices Moderate Dec 27, 2017

Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692 74102 75490 74432-01 75477 75478 75104-02 75104-03 75477-01

FDA Devices Moderate Mar 22, 2017

Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
FDA Devices Moderate Mar 22, 2017

Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
FDA Devices Moderate Mar 1, 2017

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
FDA Devices Moderate Mar 1, 2017

The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
FDA Devices Moderate Feb 22, 2017

Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
FDA Devices Low Oct 12, 2016

CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
FDA Devices Moderate Jul 27, 2016

Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM is indicate
FDA Devices Moderate Jul 27, 2016

Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000 pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures. Product U
FDA Devices Moderate Jul 27, 2016

HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and

FDA Devices Moderate Jul 27, 2016

Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM II is indicated for controlling and monitorin
FDA Devices Moderate Apr 6, 2016

CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or
FDA Devices Moderate Sep 16, 2015

CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.

Terumo Cardiovascular Syste… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name Terumo Cardiovascular Syste…? ▼
PlainRecalls indexes 204 distinct federal recall events naming Terumo Cardiovascular Systems Corporation, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Terumo Cardiovascular Syste… sit among other recalling firms? ▼
Terumo Cardiovascular Systems Corporation ranks #69 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Terumo Cardiovascular Syste…'s notices? ▼
FDA Devices accounts for 204 of this firm's 204 indexed notices.
What product category dominates Terumo Cardiovascular Syste…'s filing book? ▼
Filings for Terumo Cardiovascular Systems Corporation span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Terumo Cardiovascular Systems Corporation: 204 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Terumo Cardiovascular Systems Corporation; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026