Medtronic Perfusion Systems
116 recalls on record · Latest: Aug 5, 2026
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Agency notice ledger
Federal filing book Medtronic Perfusion Systems HEAVY-BOOK · SINGLE-AGENCY
#139 of 14,151 · 116 notices · 0.111% archive
- BOOK 116 notices
- RANK #139 of 14,151
- SHARE 0.111% archive
- AGENCY FDA Devices (116)
- CAT medical devices
- CATS 1 category
- LATEST Aug 5, 2026
- PHOTO Elekta, Inc.
Nearest notice-volume peer: Elekta, Inc. (0 notice gap)
Medtronic Perfusion Systems accounts for about 0.111% of the 104,423-notice archive on 116 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 →
Where Medtronic Perfusion Systems sits among 14,151 recalling firms
Medtronic Perfusion Systems ranks 139th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Medtronic Perfusion Systems vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
116 139th of 14151 higher than 14,012 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
Medtronic Perfusion Systems in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- C.r. Bard Inc
C.r. Bard Inc
117 notices
- Snoqualmie Go…
Snoqualmie Gourmet Ice Cream
117 notices
- Medtronic Per… (this)
Medtronic Perfusion Systems
116 notices
- Elekta, Inc.
Elekta, Inc.
116 notices
- Mitsubishi
Mitsubishi
115 notices
- Numbskull LLC
Numbskull LLC
115 notices
What this shows Medtronic Perfusion Systems holds about 0.111% of archive notices alongside 116 distinct filings.
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
FDA Devices Moderate Feb 8, 2023
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
FDA Devices Moderate Feb 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
FDA Devices Moderate Jun 1, 2022
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
FDA Devices Moderate Jan 19, 2022
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8
FDA Devices Moderate Dec 1, 2021
Cardioblate CryoFlex Surgical Ablation Console
FDA Devices Moderate Oct 13, 2021
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
FDA Devices Moderate Sep 29, 2021
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
FDA Devices Moderate Sep 29, 2021
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
FDA Devices Moderate Jun 23, 2021
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
FDA Devices Moderate Jun 23, 2021
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
FDA Devices Moderate Jun 23, 2021
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
FDA Devices Critical Apr 7, 2021
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
FDA Devices Critical Mar 24, 2021
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and ad
FDA Devices Critical Mar 24, 2021
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preser
FDA Devices Critical Mar 24, 2021
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and
FDA Devices Critical Mar 24, 2021
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet f
FDA Devices Critical Mar 24, 2021
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet functio
FDA Devices Critical Mar 24, 2021
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve pla
FDA Devices Critical Mar 24, 2021
Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with
FDA Devices Critical Mar 24, 2021
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (
FDA Devices Critical Mar 24, 2021
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Bala
FDA Devices Critical Mar 24, 2021
Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preser
FDA Devices Moderate Jul 15, 2020
Extra corporeal circuit with bio-active surface.
FDA Devices Moderate Dec 25, 2019
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
FDA Devices Moderate Feb 6, 2019
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
FDA Devices Moderate Feb 6, 2019
RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
Medtronic Perfusion Systems carries an outsized archive share
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (116 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Medtronic Perfusion Systems? ▼
PlainRecalls indexes 116 distinct federal recall events naming Medtronic Perfusion Systems, 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 Medtronic Perfusion Systems sit among other recalling firms? ▼
Medtronic Perfusion Systems ranks #139 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 Medtronic Perfusion Systems's notices? ▼
FDA Devices accounts for 116 of this firm's 116 indexed notices.
What product category dominates Medtronic Perfusion Systems's filing book? ▼
Filings for Medtronic Perfusion Systems 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.
Medtronic Perfusion Systems: 116 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 Medtronic Perfusion Systems; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026