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
10
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 10 (9%) 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.

1–25 of 116

  • SevereFDA (Devices)·Z-2807-2026·2026-08-05

    Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522

    Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula (Model 77522) due to potential pinhole leaks in the wire-wound body during use.

    Product
    EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2809-2026·2026-08-05

    Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722

    Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula Model 77722 due to potential pinhole leaks in the wire-wound body during use.

    Product
    EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2811-2026·2026-08-05

    Arterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass

    Medtronic is recalling EOPA 3D Arterial Cannula 22FR because pinhole leaks may occur during cardiopulmonary bypass, potentially causing hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

    Product
    EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2806-2026·2026-08-05

    Arterial Cannula Recall: Medtronic EOPA Blunt 22FR May Leak During Bypass

    Medtronic recalls 21,290 EOPA arterial cannulas (BLUNT 22FR) because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

    Product
    EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2026·2026-08-05

    Arterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass

    Medtronic is recalling 3,621 EOPA 3D Arterial Cannula DIL TIP 22FR units because pinhole leaks may occur during cardiopulmonary bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

    Product
    EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2808-2026·2026-08-05

    Arterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass

    Medtronic is recalling its EOPA arterial cannula because pinhole leaks may occur during bypass, risking hypovolemia, vessel injury, and organ dysfunction.

    Product
    EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2739-2026·2026-07-22

    Medtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material

    Medtronic is recalling its Bio-Medicus Adult Cannula Kit (Product Number 96530-115) used in cardiopulmonary bypass procedures due to the discovery of loose foreign material containing trace levels of blood in two units.

    Product
    Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2738-2026·2026-07-22

    Medtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material

    Medtronic is recalling certain DLP One-Piece Pediatric Arterial Cannulas (Product Number 77010) due to complaints of loose foreign material containing trace levels of blood found in the devices.

    Product
    Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2575-2026·2026-07-01

    Octopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error

    Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000, due to an assembly error where tubing was incorrectly positioned during manufacturing.

    Product
    Octopus Evolution Tissue Stabilizer, Model TS2000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2577-2026·2026-07-01

    Octopus 4 Tissue Stabilizer incorrectly assembled tubing positions

    Medtronic is recalling 590 units of the Octopus 4 Tissue Stabilizer, Model 29400 due to an assembly error where tubing was attached to the wrong positions during manufacturing.

    Product
    Octopus 4 Tissue Stabilizer, Model 29400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2576-2026·2026-07-01

    Octopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall

    Medtronic is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer Model TS2500 due to incorrect tubing positioning during manufacturing, where short and long tubes were attached to wrong locations.

    Product
    Octopus Evolution AS Tissue Stabilizer, Model TS2500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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

    Medtronic tissue stabilizer recalled after tubing was assembled in reverse

    Medtronic is recalling one lot of the Octopus Nuvo Tissue Stabilizer after identifying an assembly issue in which the short and long tubes were attached to the wrong ends of the canister.

    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

    ECMO consoles recalled after eleven reports of a blank touchscreen error

    Medtronic is recalling 167 MC3 VitalFlow Consoles after eleven reports of an E70 error code that leaves the touchscreen blank for up to two minutes during operation.

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

    Clotting time cartridges recalled over dried blood on carton labels

    Medtronic is recalling 3,850 HR-ACT clotting time cartridges after trace amounts of dry blood were observed on the external carton label and instructions in five boxes.

    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

    Oxygenators recalled after a unit failed carbon dioxide transfer requirements

    Medtronic Perfusion Systems is recalling 26 Affinity NT Oxygenators after identifying a unit with decreased CO2 gas transfer rates that did not meet performance requirements.

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

    Left heart vent catheters 13FR recalled because they may not retain shape

    DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.

    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