The Recall Desk

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

198 recalls in our database name Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) as the manufacturing or recalling firm.

What the numbers show

Total
198
Critical
8
Severe
126
Most recent
2023-06-28

Of the 198 recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) we have scored against our rubric, 8 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 126 (64%) 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.

151–175 of 198

  • ModerateFDA (Devices)·Z-2509-2020·2020-07-15

    Medtronic Azure XT SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 31,736 Azure XT SR MRI devices due to a rare communication issue that temporarily suspends certain device features.

    Product
    Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2513-2020·2020-07-15

    Medtronic Solara CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 16,667 Solara CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2505-2020·2020-07-15

    Medtronic Recalls CareLink SmartSync Device Manager Due to Feature Suspension

    Medtronic is recalling 2,773 CareLink SmartSync Device Manager units worldwide because a rare communication error may temporarily suspend certain device features.

    Product
    CareLink SmartSync Device Manager, Model Number 24970A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2508-2020·2020-07-15

    Medtronic Azure S DR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 49,513 Azure S DR MRI devices because a rare communication issue may temporarily suspend certain device features.

    Product
    Azure S DR MRI, Model Number W3DR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2510-2020·2020-07-15

    Medtronic Azure S SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 11,953 Azure S SR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Azure S SR MRI, Model Number W3SR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2506-2020·2020-07-15

    Medtronic Patient Connector Recall for Temporary Feature Suspension

    Medtronic is recalling 1,025 Patient Connectors because a rare communication error may temporarily suspend device features. The issue is unlikely to cause clinical impact and features restore automatically.

    Product
    Patient Connector, Model Number 24967
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2507-2020·2020-07-15

    Medtronic Azure XT DR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 266,252 Azure XT DR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2512-2020·2020-07-15

    Medtronic Serena CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 17,750 Serena CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2511-2020·2020-07-15

    Medtronic Percepta CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 37,360 Percepta CRT-P MRI devices due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1525-2020·2020-03-25

    Medtronic CareLink Encore Programmer Recalled for Cyber Vulnerabilities

    Medtronic is recalling CareLink Encore 29901 programmers due to improper access control and cleartext transmission of sensitive information.

    Product
    Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2020·2020-03-25

    Medtronic CareLink 2090 Programmer Recalled for Cyber Vulnerabilities

    Medtronic is recalling 23,180 CareLink 2090 Programmer devices worldwide due to improper access control and cleartext transmission of sensitive information.

    Product
    Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0240-2020·2019-11-06

    Medtronic CareLink Encore Programmer Recall for Inaccurate Longevity Estimates

    Medtronic is recalling 6,713 CareLink Encore Programmer units worldwide because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.

    Product
    Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0239-2020·2019-11-06

    Medtronic 2090 CareLink Programmer Recall for Inaccurate Longevity Estimates

    Medtronic is recalling 2090 CareLink Programmer units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.

    Product
    Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0241-2020·2019-11-06

    Medtronic CareLink SmartSync Device Manager Recall for Inaccurate Longevity Estimates

    Medtronic is recalling CareLink SmartSync Device Manager units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.

    Product
    Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2493-2019·2019-09-18

    Medtronic Micra Pacemaker Documentation Update for Tether Removal

    Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to clarify tether removal during implant.

    Product
    Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2492-2019·2019-09-18

    Medtronic Micra Pacemaker Documentation Update for Tether Removal

    Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to include specific information on tether removal during implant.

    Product
    Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1069-2019·2019-04-03

    Medtronic Pulmonary Vein Ablation Catheter Recalled for Phrenic Nerve Injury Risk

    Medtronic is recalling PVAC GOLD catheters to reduce the potential for phrenic nerve injury during cardiac ablation procedures.

    Product
    Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0845-2019·2019-02-27

    Medtronic Power Supply and Programmer Recall for Electrical Short Risk

    Medtronic is recalling 731 Power Supply 26907 and CareLink Encore 29901 Programmer units due to a potential electrical short circuit that can cause heating and smoke.

    Product
    Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0808-2019·2019-02-20

    Medtronic Pacemaker Recall: Circuit Error Affects Dual Chamber Functionality

    Medtronic is recalling 7,469 dual chamber pacemakers worldwide due to a circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0809-2019·2019-02-20

    Medtronic SENSIA Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling SENSIA dual chamber pacemakers due to a potential circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0806-2019·2019-02-20

    Medtronic Adapta Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling specific Adapta, Versa, and Sensia dual chamber pacemakers due to a circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0807-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers distributed worldwide between 2017 and 2019 due to a potential circuit error affecting device functionality.

    Product
    Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0811-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific Versa, Adapta, and Sensia pacemakers distributed worldwide from 2017 to 2019 due to a potential circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0810-2019·2019-02-20

    Medtronic Sphera DR MRI SureScan Pacemakers Recalled for Circuit Error

    Medtronic is recalling specific Sphera DR MRI SureScan pacemakers worldwide due to a circuit error that may affect device functionality when programmed to dual chamber mode.

    Product
    Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0812-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers due to a circuit error that may affect device functionality when programmed to atrial-sensing mode.

    Product
    vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
    Category
    Medical Device
    Distribution
    0 states