The Recall Desk

Manufacturer

Medtronic Perfusion Systems

116 recalls in our database name Medtronic Perfusion Systems as the manufacturing or recalling firm.

What the numbers show

Total
116
Critical
4
Severe
16
Most recent
2026-08-05

Of the 116 recalls from Medtronic Perfusion Systems we have scored against our rubric, 4 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 116

  • HighFDA (Devices)·Z-1024-2023·2023-02-08

    Affinity Fusion Oxygenator temperature monitoring adapter may loosen during cardiac surgery

    The temperature monitoring adapter on Medtronic's Affinity Fusion Oxygenator may come loose during cardiopulmonary bypass procedures. The manufacturer has received multiple complaints about this issue.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2023·2023-02-08

    Medtronic Affinity Fusion Oxygenator: Temperature Monitoring Adapter May Detach

    Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2023·2023-02-08

    Medtronic Perfusion Oxygenator Temperature Monitoring Adapter Detachment Recall

    Medtronic has recalled Custom Pack Perfusion Tubing Packs used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter on the oxygenator may detach during setup or disassembly.

    Product
    Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2023·2023-02-08

    Temperature Monitoring Adapter Detachment in Cardiopulmonary Bypass Oxygenators

    Medtronic is recalling cardiopulmonary bypass equipment because the Temperature Monitoring Adapter can come loose during setup or disassembly, potentially compromising temperature monitoring during heart surgery.

    Product
    Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2022·2022-06-01

    Medtronic Cardioblate Gemini-s Surgical Ablation System Recalled for Fractured Jaw Tips

    Medtronic is recalling 1,236 units of the Cardioblate Gemini-s surgical ablation system due to an increase in complaints about fractured jaw tips. The device is used in cardiac ablation procedures worldwide.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2022·2022-01-19

    Medtronic Perfusion Kits Recalled: Missing Endotoxin Testing

    Medtronic is recalling approximately 6,653 Custom Perfusion kits used in cardiac procedures because they were labeled as non-pyrogenic without completing required endotoxin testing.

    Product
    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)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2022·2021-10-13

    Medtronic Insertion Kits Recalled for Incorrect Guidewire Label Mix-Up

    Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.

    Product
    Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2504-2021·2021-09-29

    DLP Left Heart Vent Catheters recalled due to potential wire protrusion

    Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.

    Product
    DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2505-2021·2021-09-29

    DLP Left Heart Vent Catheters Recalled for Potential Wire Protrusion

    Medtronic recalls DLP Left Heart Vent Catheters due to risk of wire protrusion through the catheter tip. The defect could cause internal injury during cardiac procedures.

    Product
    DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Defective Welds

    Medtronic is recalling CB10R55R5 perfusion system tubing packs due to insufficient or incomplete welds that could compromise device function. The recall affects five tubing packs distributed across nine U.S. states.

    Product
    Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects

    Medtronic recalls specific lots of HY8M63R4 Adult ECC Custom Perfusion System tubing packs due to potentially insufficient or incomplete welds, which could affect performance during surgical procedures.

    Product
    Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling 14 tubing packs of its HY10J00R12 perfusion system due to insufficient or incomplete welds. The affected lot is 221227814 with a use-by date of August 28, 2022.

    Product
    Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling specific lots of BB10R94R6 Custom Perfusion System tubing packs due to incomplete or insufficient welds. The defect may affect device performance during use.

    Product
    Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.

    Product
    Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2021·2021-06-23

    Medtronic perfusion tubing packs recalled for manufacturing weld defects

    Medtronic recalls 11 packs of HY10Y54R4 Custom Perfusion System tubing manufactured with insufficient or incomplete welds. No injuries have been reported.

    Product
    Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1893-2021·2021-06-23

    Medtronic Custom Perfusion System Tubing Packs Recalled Due to Welding Defects

    Medtronic is recalling 26 tubing packs from its Custom Perfusion System (Lot 221148857) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.

    Product
    Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Defective Welds

    Medtronic is recalling specific lots of Custom Pack HY8R62R13 E Pack perfusion system tubing due to manufacturing defects. Affected lots may have incomplete welds that could compromise device function during use.

    Product
    Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2021·2021-06-23

    Medtronic Cardiac Perfusion Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling specific lots of BB8M63R5 adult cardiac perfusion tubing packs due to incomplete welds in the manufacturing process. These defects could compromise tubing integrity during cardiac surgery.

    Product
    Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling HY10L28R3 perfusion system tubing packs (lot 221679870) manufactured with insufficient or incomplete welds. The recall affects units distributed in nine U.S. states.

    Product
    Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling Custom Pack HY10D90R2 sterile perfusion system tubing packs manufactured with insufficient or incomplete welds, which could compromise device integrity during use.

    Product
    Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1894-2021·2021-06-23

    Medtronic Perfusion Tubing Packs Recalled for Insufficient or Incomplete Welds

    Medtronic is recalling specific lots of BB9G78R8 ECC perfusion system tubing packs due to insufficient or incomplete welds that may compromise device integrity.

    Product
    Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

    Medtronic is recalling 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.

    Product
    Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects

    Medtronic is recalling specific lots of HY10Z48R2 Adult ECC Custom Perfusion System tubing packs due to potential weld defects. Affected units may have insufficient or incomplete welds that could compromise device function.

    Product
    Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

    Medtronic is recalling specific lots of CB10Y89R10 custom perfusion system tubing packs due to insufficient or incomplete welds. The affected lots were distributed in nine U.S. states.

    Product
    Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide