Medtronic Inc

31 FDA enforcement actions

31 Total Recalls

0 Class I

31 Class II

0 Class III

Firm Details

Product Types: device
States: MN

All Recalls

Class II: Risk 12/04/2025 device

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 II: Risk 10/29/2025 device

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Class II: Risk 06/18/2025 device

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 II: Risk 06/18/2025 device

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 II: Risk 06/17/2025 device

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 electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
Class II: Risk 06/17/2025 device

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 electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
Class II: Risk 04/29/2025 device

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/replacement) leading to infection, hematoma, or temporary impairment.
Class II: Risk 07/11/2024 device

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 II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II: Risk 04/16/2024 device

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.