Reported Jul 30, 2025 · Ongoing
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt…
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?
5 of 5 products
| Model / number | Product as published |
|---|---|
D00U005 | Cobalt Crome application, Software |
D00U009 | Claria Amplia Compia application, Software |
D00U010 | Evera MRI application, Software |
D00U011 | Visia AF application, Software |
D00U012 | Viva Brava Evera 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
- 22091 total devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
This product could cause temporary or reversible health problems — stop using it.
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