The Recall Desk

Manufacturer

Medtronic, Inc.

109 recalls in our database name Medtronic, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
109
Critical
0
Severe
8
Most recent
2026-05-06

Of the 109 recalls from Medtronic, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (7%) 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 109

  • HighFDA (Devices)·Z-1948-2026·2026-05-06

    Medtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs

    Medtronic Sphere-9 Catheters used for cardiac ablation may trigger ventricular fibrillation during radiofrequency therapy in patients with Biotronik implantable defibrillators due to an interaction between catheter current flow and a device safety feature.

    Product
    Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1098-2026·2026-01-21

    Venous stents recalled over a nitinol anomaly that reduces deployed diameter

    Medtronic is recalling 442 Abre Venous Self-Expanding Stent Systems because a nitinol anomaly causes a reduced stent diameter and radial force when deployed, which may result in migration.

    Product
    Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2026·2025-12-10

    Kidney tests recalled for distribution without premarket approval or clearance

    Get Tested International AB is recalling 100 units of its Kidney Test because the product was distributed without premarket approval or clearance.

    Product
    Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2168-2025·2025-07-30

    SmartSync Patient Connector limited the window to abort high voltage therapy

    The Medtronic CareLink SmartSync Patient Connector is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.

    Product
    Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2169-2025·2025-07-30

    CareLink SmartSync limited the window to abort a high voltage therapy

    Medtronic CareLink SmartSync Device Manager is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.

    Product
    Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2127-2025·2025-07-23

    Medtronic SmartSync software update removes an erroneous electrical reset message

    Medtronic SmartLink Software on the SmartSync Patient Connector is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 3,909 units affected.

    Product
    Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2128-2025·2025-07-23

    Medtronic CareLink SmartSync software update removes an erroneous reset message

    Medtronic SmartLink software on the CareLink SmartSync Device Manager is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 5,418 units affected.

    Product
    Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobal
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1924-2025·2025-06-18

    Azure S DR MRI SureScan Pacemakers Recalled for Battery Failure Risk

    Medtronic Azure S DR MRI SureScan pacemakers may experience sudden battery power failure without warning, potentially interrupting therapy and leading to cardiac arrest or hospitalization. Affected devices are being recalled internationally.

    Product
    Azure S DR MRI SureScan, Product number W3DR01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3152-2024·2024-09-25

    Medtronic CareLink 2090 Programmer Recall: Autonomous Cursor Motion

    Medtronic is recalling CareLink 2090 Programmers (serial number prefixes PKK0 and PKK1) worldwide due to potential autonomous cursor motion when Finger Touchscreen capability is enabled with software version 3.2 or higher. Approximately 18,788 units are affected.

    Product
    2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Pr
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2202-2024·2024-07-03

    Implantable Cardioverter Defibrillator Recalled Due to Manufacturing Weld Defect

    Medtronic is recalling 26 MIRRO MRI DR SureScan Implantable Cardioverter Defibrillators due to a manufacturing defect involving a weld crack that could affect device function.

    Product
    MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2024·2024-07-03

    Medtronic Implantable Defibrillator Recalled Due to Manufacturing Weld Crack

    Medtronic is recalling 14 Cobalt XT HF CDT-D MRI SureScan implantable defibrillators due to a manufacturing weld defect that could cause device failure.

    Product
    Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic is recalling 14 units of EVERA MRI S VR SureScan implantable cardioverter defibrillators (Model DVMC3D4) due to potential weld cracks discovered during manufacturing. No patient injuries have been reported.

    Product
    EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2024·2024-07-03

    Medtronic MIRRO MRI ICD devices recalled for manufacturing weld crack defect

    Medtronic recalls 13 MIRRO MRI VR SureScan implantable cardioverter defibrillators (ICDs) due to a manufacturing weld crack. The defect was identified and caused device failure during the manufacturing leak check quality control test.

    Product
    MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2024·2024-07-03

    Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalls 46 PRIMO MRI VR SureScan implantable cardioverter defibrillators due to a manufacturing defect. Weld cracks identified during manufacturing quality checks could cause device failure.

    Product
    PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2207-2024·2024-07-03

    Medtronic COBALT DR MRI SureScan ICD Recalled Due to Manufacturing Weld Crack

    Medtronic is recalling 36 COBALT DR MRI SureScan implantable cardioverter defibrillators due to a weld crack manufacturing defect. The defect was identified during manufacturing quality checks.

    Product
    COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2024·2024-07-03

    Medtronic COBALT VR MRI SureScan implantable defibrillators recalled for manufacturing defect

    Medtronic is recalling 4 COBALT VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing defect involving a weld crack identified during quality control testing.

    Product
    COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2024·2024-07-03

    Medtronic EVERA S VR Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect

    Medtronic is recalling EVERA S VR implantable cardioverter defibrillators due to a potential manufacturing defect involving a weld crack that can cause device failure. The defect was identified during manufacturing leak testing.

    Product
    EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect

    Medtronic is recalling eight COBALT XT VR MRI SureScan implantable cardioverter defibrillators due to weld cracks that caused device failure during manufacturing.

    Product
    COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2024·2024-07-03

    Implantable Defibrillator Recalled for Manufacturing Weld Crack Defect

    Medtronic is recalling 11 units of the COBALT XT HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillator due to a manufacturing defect involving weld cracks that failed quality control testing.

    Product
    COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2024·2024-07-03

    Implantable defibrillator recalled for manufacturing defect causing device failure risk

    Medtronic is recalling five implantable defibrillators due to a manufacturing defect where weld cracks caused devices to fail quality testing. The defective devices were identified during manufacturing and did not reach patients.

    Product
    Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2024·2024-07-03

    Medtronic COBALT DR MRI ICD Recalled for Manufacturing Defect

    Nine Medtronic COBALT DR MRI implantable cardioverter defibrillators are recalled due to a weld crack that caused devices to fail manufacturing quality checks.

    Product
    COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2024·2024-07-03

    Medtronic COBALT XT HF CRT-D implantable defibrillator recalled for manufacturing defects

    Medtronic is recalling 8 units of the COBALT XT HF CRT-D MRI SureScan implantable cardioverter defibrillator due to manufacturing defects identified during quality control testing.

    Product
    COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2024·2024-07-03

    Medtronic MIRRO MRI implantable defibrillator recalled for weld defect

    Medtronic is recalling 3 MIRRO MRI DR SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality checks. The defect was detected during manufacturing before devices reached patients.

    Product
    MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2024·2024-07-03

    Medtronic PRIMO MRI DR SureScan Cardioverter Defibrillators Recalled for Manufacturing Defect

    Medtronic is recalling two PRIMO MRI DR SureScan implantable cardioverter defibrillators due to a potential manufacturing defect involving weld cracks detected during manufacturing quality testing.

    Product
    PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2024·2024-07-03

    Medtronic ICD Implants Recalled for Manufacturing Weld Crack Defects

    Medtronic recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.

    Product
    CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide