Medtronic CareLink SmartSync (Medtronic) – Test Abort Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
Brand
Medtronic, Inc.
Lot Codes / Batch Numbers
1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5, 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5, 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, Updated Software Version 4.4.6, 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5, 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2, 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2, 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2, 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2, 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.
Products Sold
1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; 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, Updated Software Version 4.4.6; 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.
Medtronic, Inc. is recalling Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software compone due to In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter dated 6/18/25 was sent to customers. Customer Actions: "Update SmartSync (to version 4.2.3 or higher). Refer to release notes provided by your local Medtronicrepresentative for update instructions. If needed, Medtronic representatives are available to work with you toinstall or update the SmartSync application(s) on your tablet. See Appendix for instructions on how to verify thesoftware update is complete. "Sign and return the enclosed confirmation form and share this notice with those who need to be aware withinyour organization or with any organization where SmartSync may be in use. Questions regarding this informationshould be directed to the local Medtronic Representative or Medtronic Programmer Technical Services at 800-638-1991, Option 1.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026