The Recall Desk
HighFDA (Devices)·Z-2169-2025·Announced 2025-07-30

Medtronic CareLink SmartSync Device Manager software abort button defect recall

Medtronic is recalling CareLink SmartSync Device Manager software versions due to a defective abort button. The abort button does not properly stop induction testing, limiting users' ability to cancel high voltage therapy delivery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of cardiac device software with a defective safety feature (abort button) that limits user ability to cancel high voltage therapy delivery. No hospitalizations or injuries have been reported, placing this in the risk-of-harm category without yet-reported injury.

Plain-English summary

Medtronic, Inc. is recalling versions of the CareLink SmartSync Device Manager, Model 24967A, including multiple software components (Cobalt Crome, Claria Amplia Compia, Evera MRI, Visia AF, and Viva Brava Evera applications). The recall affects 22,091 devices distributed worldwide and throughout the United States.

The defect: In prior software versions, the Abort button does not properly stop the test that was selected. During an induction test—a critical phase of device setup—there is a limited window of time for the user to abort therapy. This limitation reduces the user's ability to cancel a high voltage therapy delivery in a timely manner.

Medtronic has updated the affected software versions (6.5.5, 9.5.2, 4.4.6, 3.5.5, 3.4.2, and 3.7.5, depending on the component). Users should verify that their device software has been updated to the corrected version.

If you have questions about whether your device is affected, contact Medtronic or your healthcare provider.

The recalled product

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
Manufacturer
Medtronic, Inc.
Category
Medical Device — Cardiac device software
Hazard
  • software-defect
  • therapy-abort-failure
  • high-voltage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. Software Model Number
  • D00U003
  • GTIN 00763000002039
  • Updated Software Version 6.5.5
  • 2. Software Model Number
  • D00U004
  • GTIN 00763000002046
  • 3. Software Model Number
  • D00U005
  • GTIN 00763000002053
  • Updated Software Version 9.5.2
  • 4. Software Model Number
  • D00U006
  • GTIN 00763000397852
  • Updated Software Version 4.4.6
  • 5. Software Model Number
  • D00U007
  • GTIN 00763000397869
  • 6. Software Model Number
  • D00U008

Distribution

Distributed nationwide across the United States.

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