The Recall Desk
SevereFDA (Devices)·Z-2128-2025·Announced 2025-07-23

Medtronic CareLink SmartSync Device Manager software recalled for erroneous reset message

The Medtronic CareLink SmartSync Device Manager software displays a false electrical reset message, potentially prompting unnecessary device removal. Two patients have undergone unnecessary device explant procedures due to this error.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving documented instances of unnecessary surgical procedures (device explant) resulting from a software display error. The two documented unnecessary device explants constitute significant adverse events meeting the criteria for Severe classification.

Plain-English summary

Medtronic is recalling software for the CareLink SmartSync Device Manager, a system used to manage and monitor implanted cardiac devices. The software displays an erroneous electrical reset message when clinicians interrogate (communicate with) the device, falsely indicating that a reset has occurred.

In reality, no reset occurs, and there are no actual changes to device parameters or loss of diagnostics. However, the misleading message can cause confusion and lead clinicians to consider unnecessary device revision or explant (removal).

As of April 30, 2025, Medtronic has documented 39 reports of this display error. Two patients have undergone unnecessary device explant procedures based on the false message. Affected versions are identified by their software model numbers and GTINs, and corrected software versions are available from Medtronic.

The recalled product

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
Manufacturer
Medtronic, Inc.
Category
Medical Device — Cardiac Device Management Software
Hazard
  • software-error
  • false-alert
  • unnecessary-procedure

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

Distribution scope not specified by the agency.

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