CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report
CareLink SmartSync Device Manager recalled by Medtronic
Medtronic is recalling Medtronic CareLink SmartSync Device Manager, distributed nationwide in the US. The recall was initiated on 18 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2169-2025
- FDA event ID
- 97130
- Recalling firm
- Medtronic, Mounds View, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jun 2025
- FDA classified
- 23 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 18 Jun 2025 | Recall initiated by company | |
| 23 Jul 2025 | Classified by FDA | +35 days |
| 30 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Is CareLink SmartSync Device Manager recalled?
Yes. Medtronic recalled CareLink SmartSync Device Manager on 18 Jun 2025. The recall is Class II and its status is Ongoing. Recall number Z-2169-2025.
Why was it 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.
Which lots are affected?
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.
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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