Medtronic, Inc.: Device Recall

Recall #Z-0726-2026 · 10/29/2025

Class II: Risk

Recall Details

Recall Number: Z-0726-2026
Classification: Class II
Product Type: Device
Recalling Firm: Medtronic, Inc.
Status: Ongoing
Date Initiated: 10/29/2025
Location: Mounds View, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6591 units

Reason for Recall

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Product Description

Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

Distribution Pattern

Worldwide - US Nationwide distribution.

Other Recalls by Medtronic, Inc.

Class II: Risk 12/04/2025

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 06/18/2025

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

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

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

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.

View all recalls by Medtronic, Inc. →

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.