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.

101–116 of 116

  • HighFDA (Devices)·Z-0900-2018·2018-03-14

    Medtronic BIO CAL Temperature Controller Recalled Due to Cleaning Protocol Issues

    Medtronic is recalling BIO CAL Temperature Controllers because it cannot develop a cleaning protocol that meets current industry standards. Users are advised to discontinue use and dispose of the devices.

    Product
    BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0646-2018·2018-02-28

    Medtronic Cardiotomy Reservoir Recall for Possible Sterile Barrier Breach

    Medtronic is recalling Affinity NT Cardiotomy Venous Reservoirs due to a possible sterile barrier breach in the pouch.

    Product
    Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0645-2018·2018-02-28

    Medtronic Recalls Affinity NT Cardiotomy Reservoirs Due to Sterile Barrier Breach

    Medtronic is recalling Affinity NT Cardiotomy/Venous Reservoirs because of a possible sterile barrier breach in the pouch.

    Product
    Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed whi
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0535-2018·2018-02-14

    Medtronic Custom Perfusion Systems Recalled Due to Valve Flow Defect

    Medtronic is recalling 2,914 custom perfusion systems because Terumo OPS valves may lack flow. The devices are used in cardiopulmonary bypass surgery.

    Product
    Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2764-2017·2017-08-02

    Medtronic Recalls DLP Extension Line Adapters Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Extension Line Adapters because small pinholes were found in a single packaging configuration of sterile pouches.

    Product
    DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2017·2017-08-02

    Medtronic Recalls DLP Pressure Monitoring Extension Line Adapters

    Medtronic Perfusion Systems is recalling DLP Pressure Monitoring Extension Line Adapters due to small pinholes in sterile packaging.

    Product
    DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2765-2017·2017-08-02

    Medtronic DLP Antegrade/Retrograde Adapter Recalled for Packaging Pinholes

    Medtronic is recalling DLP Antegrade/Retrograde Adapters because small pinholes were found in a single packaging configuration of sterile pouches.

    Product
    DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2768-2017·2017-08-02

    Medtronic Recalls DLP Pressure Display Sets Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets because small pinholes were found in the sterile packaging.

    Product
    DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2766-2017·2017-08-02

    Medtronic Recalls DLP Cardioplegia Adapters Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Cardioplegia Adapters with Pressure Port because small pinholes were identified in a single packaging configuration of sterile pouches.

    Product
    DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1023-2016·2016-03-09

    Medtronic Perfusion Tubing Packs Recalled Due to Cuvette Safety Alert

    Medtronic is recalling specific lots of Perfusion Tubing Packs because they contain Terumo CVS cuvettes subject to an Urgent Safety Alert.

    Product
    Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This pro
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0268-2016·2015-11-18

    Medtronic Perfusion Tubing Packs Recalled for Potential Header Bag Seal Breach

    Medtronic is recalling 496 Perfusion Tubing Packs due to a potential breach in the header bag seal. The affected lots were distributed nationwide in the US.

    Product
    Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are inte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2015·2015-09-16

    Medtronic Hemocor Hemoconcentrators Recalled for Low Ultrafiltration Performance

    Medtronic Perfusion Systems is recalling Hemocor Hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2736-2015·2015-09-16

    Medtronic Perfusion Tubing Packs Recalled for Low Ultrafiltration Performance

    Medtronic is recalling specific perfusion tubing packs and hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2420-2015·2015-08-26

    Medtronic EOPA Arterial Cannula Recalled for Missing Guidewire

    Medtronic is recalling EOPA Arterial Cannulas (Lot 2015060544) because they were shipped without the required guidewire.

    Product
    Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2015·2015-07-08

    Medtronic Recalls DLP Femoral Arterial Cannulas Due to Connection Issues

    Medtronic is recalling specific lots of DLP Femoral Arterial Cannulas because users reported difficulty connecting the device to perfusion circuit tubing.

    Product
    Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter tran
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0531-2015·2014-12-17

    Medtronic Recalls Affinity Fusion Oxygenators Due to Damaged Heat Exchangers

    Medtronic Perfusion Systems is recalling 168 Affinity Fusion Oxygenators with Carmeda Bioactive Surface due to damaged heat exchangers.

    Product
    The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blo
    Category
    Medical Device
    Distribution
    2 states