Recall Z-2127-2025
Medtronic, Inc. · initiated June 17, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 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.
Codes / lots: 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.
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-2127-2025
- Initiated
- June 17, 2025
- Posted by FDA
- July 17, 2025
- Product code
- KRG – Programmer, Pacemaker
- Quantity
- 3909 units
- Distribution
- Worldwide
- Recalling firm
- Medtronic, Inc., Mounds View, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2128-2025 Class II | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number…A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update… | 06/17/2025Open, Classified |