RegWardenFDA facility compliance records
Facility

MEDTRONIC PERFUSION SYSTEMS

30 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2015: 2 recalls; 2016: 3 recalls, 1 inspections; 2017: 2 recalls; 2019: 1 recalls; 2020: 1 recalls; 2021: 2 recalls; 2022: 6 recalls; 2023: 4 recalls; 2024: 3 recalls; 2025: 5 recalls; 2026: 1 recalls22015420162201720181201912020220216202242023320245202512026
  • Recalls (30)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

20261 record
  • Class IIOngoing2026-03-11
    Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observa…
20255 records
  • Class IIOngoing2025-12-04
    Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
  • Class IIOngoing2025-10-29
    There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
  • Class IIOngoing2025-06-18
    In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
  • Class IIOngoing2025-06-17
    A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an el…
  • Class IIOngoing2025-04-29
    Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant…
20243 records
  • Class IIOngoing2024-07-11
    Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
  • Class IIOngoing2024-04-16
    Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
  • Class IIOngoing2024-02-16
    There is a potential for sterile package breach.
20234 records
  • Class IIOngoing2023-12-07
    During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some bat…
  • Class IICompleted2023-11-20
    Seal defects could compromise the ability of the product packaging to maintain sterility.
  • Class IIOngoing2023-11-03
    It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electro…
  • Class IIOngoing2023-10-12
    The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. B…
20226 records
  • Class IIOngoing2022-07-14
    Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
  • Class IIOngoing2022-06-24
    Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
  • Class IOngoing2022-05-05
    Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
  • Class IOngoing2022-04-14
    The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concen…
  • Class IIOngoing2022-03-30
    Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
  • Class IOngoing2022-03-02
    There is potential for the capsule bond to break during the procedure.
20212 records
20201 record
  • Class IICompleted2020-07-13
    The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
20191 record
  • Class IITerminated2019-05-21
    Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
20172 records
20163 records
  • Class IITerminated2016-11-16
    Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion® Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tu…
  • Class IITerminated2016-11-10
    Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observ…
  • Class IITerminated2016-02-23
    Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection a…
20152 records
  • Class IITerminated2015-11-09
    Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
  • Class IITerminated2015-09-29
    64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

FDA inspections (1)

  • NAI2016-06-17
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MEDTRONIC PERFUSION SYSTEMS (FEI 1718389) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1718389-medtronic-perfusion-systems/

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