Recall archive / FDA device enforcement
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following soft... — FDA record Z-2128-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medtronic, Inc.
- Quantity
- 5418 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2128-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 23, 2025
- Recall initiation date
- Jun 17, 2025
- Center classification date
- Jul 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.