Medical Device Recall Search

Recall Search

Medical Device Recall Search

Search live FDA recall data for medical devices. Enter a device type, brand name, or body area. Results come directly from the FDA's device recall database, updated continuously.

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282 results for “pacemaker”

  • Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. T…

    Recalling firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    Status
    Terminated
    Date initiated
    2015-09-15
    Reason for recall
    Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.

  • PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, tha…

    Recalling firm
    St Jude Medical Inc.
    Status
    Terminated
    Date initiated
    2017-08-28
    Reason for recall
    New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

  • PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply a…

    Recalling firm
    St Jude Medical Inc.
    Status
    Terminated
    Date initiated
    2017-08-28
    Reason for recall
    New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

  • PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power …

    Recalling firm
    St Jude Medical Inc.
    Status
    Terminated
    Date initiated
    2017-08-28
    Reason for recall
    New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

  • PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that p…

    Recalling firm
    St Jude Medical Inc.
    Status
    Terminated
    Date initiated
    2017-08-28
    Reason for recall
    New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

  • PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply…

    Recalling firm
    St Jude Medical Inc.
    Status
    Terminated
    Date initiated
    2017-08-28
    Reason for recall
    New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

  • BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4.…

    Recalling firm
    AZIYO BIOLOGICS
    Status
    Terminated
    Date initiated
    2019-08-21
    Reason for recall
    Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

  • CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. …

    Recalling firm
    AZIYO BIOLOGICS
    Status
    Terminated
    Date initiated
    2019-08-21
    Reason for recall
    Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

  • Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intend…

    Recalling firm
    Medtronic Inc. Cardiac Rhythm Managment
    Status
    Terminated
    Date initiated
    2007-08-27
    Reason for recall
    An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting

  • regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray …

    Recalling firm
    Resource Optimization & Innovation Llc
    Status
    Terminated
    Date initiated
    2015-04-22
    Reason for recall
    The kits contain an equipment glove component which may contain splits or holes compromising the sterility.