Reported Jul 23, 2025 · Ongoing
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software…
Medtronic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic, Inc. · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
11 of 11 products
| Model / number | Product as published |
|---|---|
D00U003 | Azure Astra application, Software |
D00U004 | Percepta Serena Solara application, Software |
D00U005 | Cobalt Crome application, Software |
D00U006 | Micra VR application, Software |
D00U007 | Micra AV application, Software |
D00U008 | Viva Consulta Syncra Advisa Ensura application, Software |
D00U009 | Claria Amplia Compia application, Software |
D00U010 | Evera MRI application, Software |
D00U011 | Visia AF application, Software |
D00U012 | Viva Brava Evera application, Software |
D00U022. | Micra VR2 AV2 application, Software |
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published 00763000002039Software Model Number, D00U003, , Updated Software Version 6.5.5 00763000002046Software Model Number, D00U004, , Updated Software Version 6.5.5 00763000002053Software Model Number, D00U005, , Updated Software Version 9.5.2 00763000397852Software Model Number, D00U006, , Updated Software Version 4.4.6 00763000397869Software Model Number, D00U007, , Updated Software Version 4.4.6 00763000397876Software Model Number, D00U008, , Updated Software Version 3.5.5 00763000397883Software Model Number, D00U009, , Updated Software Version 3.4.2 00763000397890Software Model Number, D00U010, , Updated Software Version 3.4.2 00763000397906Software Model Number, D00U011, , Updated Software Version 3.4.2 00763000397913Software Model Number, D00U012, , Updated Software Version 3.4.2 00763000544300Software Model Number, D00U022, , Updated Software Version 3.7.5. - Amount recalled
- 3909 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
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.
This product could cause temporary or reversible health problems — stop using it.
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