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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Medtronic SmartSync Patient Connectors Recalled for Abort Button Failure

Agency Publication Date: July 23, 2025
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Summary

Medtronic, Inc. is recalling approximately 22,091 CareLink SmartSync Patient Connectors (Model 24967) and Device Managers (Model 24967A). These devices use software applications to manage cardiac implants, but a software error in previous versions causes the "Abort" button to stop working during specific induction tests. This defect limits a clinician's ability to cancel the delivery of high-voltage therapy when needed. Medtronic has released updated software versions to correct this issue.

Risk

If the "Abort" button fails during a procedure, a clinician may be unable to stop the delivery of a high-voltage shock within the expected window. This could result in the patient receiving unnecessary or unintended high-voltage therapy.

What You Should Do

  1. The recalled products are Medtronic CareLink SmartSync Patient Connectors (Model 24967) and Device Managers (Model 24967A) using various software applications including Cobalt Crome, Claria Amplia Compia, Evera MRI, Visia AF, and Viva Brava Evera.
  2. Check the software model number and version on your device manager or patient connector. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medtronic CareLink SmartSync Patient Connector
Variants: Cobalt Crome application, Claria Amplia Compia application, Evera MRI application, Visia AF application, Viva Brava Evera application
Model / REF:
24967
D00U003
D00U004
D00U005
D00U006
D00U007
D00U008
D00U009
D00U010
D00U011
D00U012
D00U022
GTIN:
00763000002039
00763000002046
00763000002053
00763000397852
00763000397869
00763000397876
00763000397883
00763000397890
00763000397906
00763000397913
00763000544300

Recall affects prior SmartSync application versions. Corrected versions include 6.5.5, 9.5.2, 4.4.6, 3.5.5, 3.4.2, and 3.7.5 depending on the software model.

Product: Medtronic CareLink SmartSync Device Manager
Variants: Cobalt Crome application, Claria Amplia Compia application, Evera MRI application, Visia AF application, Viva Brava Evera application
Model / REF:
24967A
D00U003
D00U004
D00U005
D00U006
D00U007
D00U008
D00U009
D00U010
D00U011
D00U012
D00U022
GTIN:
00763000002039
00763000002046
00763000002053
00763000397852
00763000397869
00763000397876
00763000397883
00763000397890
00763000397906
00763000397913
00763000544300

Recall affects prior SmartSync application versions. Corrected versions include 6.5.5, 9.5.2, 4.4.6, 3.5.5, 3.4.2, and 3.7.5 depending on the software model.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97130
Status: Active
Manufacturer: Medtronic, Inc.
Sold By: Authorized Medical Distributors; Medtronic Sales Representatives
Manufactured In: United States
Units Affected: 2 products (22091 total devices)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.