PlainRecalls

Terumo Cardiovascular Systems Corporation

Compiled from official public sources by the editorial team.

204 recalls on record · Latest: Jul 2, 2025

Terumo Cardiovascular Systems Corporation Recall Insight

Terumo Cardiovascular Systems Corporation appears on 204 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.201% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 2, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 43 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Feb 20, 2013 to Jun 3, 2015.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jun 3, 2015

Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorp…

FDA Devices Moderate Jun 3, 2015

100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorp…

FDA Devices Moderate Feb 25, 2015

Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of pat…

FDA Devices Moderate Jul 30, 2014

Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Can…

FDA Devices Moderate Jul 30, 2014

Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous …

FDA Devices Moderate Jul 30, 2014

Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated…

FDA Devices Moderate Jul 30, 2014

Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return C…

FDA Devices Moderate Jul 30, 2014

Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the asc…

FDA Devices Moderate Jul 30, 2014

Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascend…

FDA Devices Moderate Jul 30, 2014

Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Retur…

FDA Devices Moderate Jul 30, 2014

Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in…

FDA Devices Moderate Jul 30, 2014

CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation…

FDA Devices Moderate Jul 30, 2014

Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: …

FDA Devices Moderate Jul 30, 2014

Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aor…

FDA Devices Moderate Jul 30, 2014

Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of …

FDA Devices Moderate Jul 30, 2014

Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Veno…

FDA Devices Moderate Jul 23, 2014

Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.

FDA Devices Moderate Jul 23, 2014

Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.

FDA Devices Moderate Jul 23, 2014

Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 7…

FDA Devices Moderate Jul 16, 2014

Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

FDA Devices Moderate Jul 16, 2014

Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)

FDA Devices Moderate May 28, 2014

CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Mo…

FDA Devices Moderate Mar 26, 2014

Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Cat…

FDA Devices Moderate Mar 26, 2014

Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous Return C…

FDA Devices Moderate Mar 26, 2014

Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating The Sarns Malleable Dual-stage…

FDA Devices Moderate Mar 26, 2014

Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Veno…

FDA Devices Moderate Mar 26, 2014

Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Cat…

FDA Devices Moderate Mar 26, 2014

Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Veno…

FDA Devices Moderate Mar 26, 2014

Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sarns Malleable Dual-stage V…

FDA Devices Moderate Mar 5, 2014

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus Endoscopic V…

FDA Devices Moderate Jan 8, 2014

Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line

FDA Devices Moderate Nov 27, 2013

Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERIL…

FDA Devices Moderate Nov 20, 2013

Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" co…

FDA Devices Moderate Nov 20, 2013

Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" co…

FDA Devices Moderate Nov 20, 2013

Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for…

FDA Devices Moderate Nov 20, 2013

Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" conn…

FDA Devices Moderate Oct 2, 2013

Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular P…

FDA Devices Moderate Aug 21, 2013

100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulatio…

FDA Devices Moderate Aug 21, 2013

Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicate…

FDA Devices Moderate Aug 21, 2013

220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulatio…

FDA Devices Moderate Aug 21, 2013

Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in ext…

FDA Devices Moderate Aug 21, 2013

Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in …

FDA Devices Moderate Aug 21, 2013

Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extr…

FDA Devices Moderate Jul 24, 2013

CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when con…

FDA Devices Moderate Jul 24, 2013

CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopu…

FDA Devices Moderate Jul 24, 2013

CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when conti…

FDA Devices Moderate Jul 24, 2013

CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use durin…

FDA Devices Moderate Jul 24, 2013

CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedure…

FDA Devices Moderate Jul 3, 2013

Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat …

FDA Devices Moderate Feb 20, 2013

Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Terumo Cardiovascular Systems Corporation with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.