Medtronic SmartLink Software (Medtronic) – Display Error Update (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 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
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 SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the foll due to A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an err. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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