The Recall Desk

Manufacturer

Medtronic Perfusion Systems

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

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.

1–25 of 73

  • SevereFDA (Devices)·Z-2216-2026·2026-05-27

    Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk

    Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94215T) due to a potential sterile barrier breach. The affected product is a cardiopulmonary bypass vascular catheter distributed worldwide.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2218-2026·2026-05-27

    Medtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk

    Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94725), a cardiopulmonary bypass catheter, because the sterile barrier may be breached, potentially allowing contamination. The cannulas were distributed worldwide.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2026·2026-05-27

    Medtronic DLP Retrograde Cannula 13FR Model 94913L Recall

    Medtronic is recalling certain lots of DLP Retrograde Cannula (Model 94913L), a cardiopulmonary bypass catheter, due to potential sterile barrier breaches. The affected device was distributed worldwide.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2026·2026-05-27

    Medtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach

    Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94115T) cardiopulmonary bypass vascular catheters due to potential sterile barrier breach. The affected product has been distributed worldwide.

    Product
    Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2026·2026-05-27

    Medtronic DLP Retrograde Cannula cardiopulmonary bypass catheter

    Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94915), a cardiopulmonary bypass vascular catheter, due to potential sterile barrier breach.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2026·2026-05-27

    Medtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier

    Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula Model 94665 due to potential sterile barrier breach. The product is used in cardiopulmonary bypass procedures worldwide.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2026·2026-05-27

    Medtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall

    Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94913), a cardiopulmonary bypass vascular catheter, due to a potential sterile barrier breach.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2026·2026-05-27

    Medtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall

    Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94113T), a cardiopulmonary bypass catheter, due to potential sterile barrier breach in the product.

    Product
    Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2222-2026·2026-05-27

    Medtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach

    Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94965) due to potential sterile barrier breach. The cannula is used in cardiopulmonary bypass procedures.

    Product
    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2026·2026-03-04

    Octopus Nuvo Tissue Stabilizer recalled for tubing assembly error

    Medtronic is recalling Octopus Nuvo Tissue Stabilizer units due to an assembly error where tubing was incorrectly positioned. The short tube was attached to the bottom instead of the top, contrary to design specifications.

    Product
    Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0509-2026·2025-11-26

    MC3 VitalFlow Console touch screen becomes temporarily unresponsive

    Medtronic MC3 VitalFlow Console blood pumps may display an E70 error causing the touch screen to go blank and become unresponsive for up to two minutes, though the pump continues operating normally. No injuries have been reported.

    Product
    MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0539-2026·2025-11-26

    Medtronic ACT Cartridges Recalled for Blood Contamination on Packaging

    Medtronic is recalling 3,850 units of HR-ACT Cartridges due to trace amounts of dry blood found on external carton labels and instructions in one lot. No illnesses have been reported.

    Product
    Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2026·2025-11-19

    Affinity NT Oxygenator recalled for decreased CO2 gas transfer

    Medtronic Perfusion Systems is recalling 26 Affinity NT Oxygenator units with decreased CO2 gas transfer rates not meeting performance specifications. The units were distributed in Arizona, California, and Tennessee.

    Product
    Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2480-2025·2025-09-10

    Medtronic DLP Left Heart Vent Catheter May Not Retain Shape

    Medtronic is recalling 34,549 DLP Left Heart Vent Catheters (Model 12113) because the catheters may not retain their shape. The defect affects devices distributed worldwide and could compromise catheter function during cardiac surgery.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2481-2025·2025-09-10

    DLP Left Heart Vent Catheter Recalled for Loss of Shape Retention

    Medtronic is recalling DLP Left Heart Vent Catheters (Model 12110) because they may not retain their shape during use. This defect could affect device function in cardiac surgical procedures.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2482-2025·2025-09-10

    DLP Left Heart Vent Catheter May Not Retain Shape During Use

    Medtronic is recalling 25,261 DLP Left Heart Vent Catheters (Model 12115) because they may not retain their shape. This Class I recall affects catheters distributed worldwide and in the US.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1306-2025·2025-03-19

    Aortic Root Cannula Recall for Loose Male Luer Component

    Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.

    Product
    Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2025·2025-01-29

    Medtronic Recalls EOPA Arterial Cannula Models for Labeling Errors

    Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.

    Product
    EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2025·2025-01-29

    Medtronic Arterial Cannula Recall Due to Incorrect Labeling

    Medtronic Perfusion Systems is recalling Select Series Angled Tip Arterial Cannulas (Model 72422) due to incorrect labeling. The recall involves 440 units distributed nationwide.

    Product
    Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2025·2025-01-29

    Medtronic Pediatric Arterial Cannulae Recalled for Incorrect Labeling

    Medtronic is recalling 745 DLP Pediatric Arterial Cannulae (Models 77008 and 77014) due to incorrect labeling affecting seven manufactured lots distributed nationwide and worldwide.

    Product
    DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3128-2024·2024-09-18

    Medtronic Venous Cannulae: Wrong Product in Incorrect Packaging

    Medtronic Perfusion Systems is recalling 290 units of DLP Single Stage Venous Cannulae due to a manufacturing error where straight-tip cannulae were placed into packaging labeled for right-angle metal-tip cannulae.

    Product
    Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2024·2024-07-31

    Medtronic TourniKwik Tourniquet Set Recalled for Incorrect Component

    Medtronic is recalling 636 units of TourniKwik Tourniquet Sets due to incorrect components placed in four manufactured lots. Distribution includes the US states of Minnesota, Massachusetts, Utah, California, Florida, Japan, and Slovenia.

    Product
    TourniKwik Tourniquet Set (CFN 79012)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2024·2024-05-22

    Medtronic Arteriotomy Cannula Recall Due to Potential Unsealed Sterile Packing

    Medtronic is recalling 7,935 units of I.M.A. Arteriotomy Cannula Model 31001 worldwide due to potential for unsealed sterile packing. Affected healthcare providers should verify lot numbers against inventory.

    Product
    Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1798-2024·2024-05-22

    Medtronic Tourniquet Sets recalled for potential unsealed sterile packing

    Medtronic is recalling 1760 tourniquet kits due to potential for unsealed sterile packing. These surgical devices may have compromised sterilization barriers.

    Product
    Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
    Category
    Medical Device
    Distribution
    0 states