—#214620

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. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.

FDA product code: KRG — Programmer, Pacemaker
Device class: Class 3
Medical specialty: Cardiovascular
PMA numbers: P890003, P980016, P980035, P010015, P010031, P150033
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTIFICATION to its consignees on 06/18/2025 via UPS 2nd day delivery. The notice announced that a software update was available for the Medtronic CareLink SmartSync Device Manager (SmartSync), explained the issue which the update was correcting, risk, and requested the following: Customer Actions: " Update SmartSync (to version 4.2.3 or higher). Refer to release notes provided by your local Medtronic representative for update instructions. If needed, Medtronic representatives are available to work with you to install or update the SmartSync application(s) on your tablet. See Appendix for instructions on how to verify the software update is complete. " Sign and return the enclosed confirmation form and share this notice with those who need to be aware within your organization or with any organization where SmartSync may be in use. Questions regarding this information should be directed to the local Medtronic Representative or Medtronic Programmer Technical Services at 800-638-1991, Option 1.

Recalling firm

Firm: Medtronic, Inc.
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2025-06-17
Posted by FDA: 2025-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214620. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.