CLASS II ONGOING Device recall · Reported 12 May 2021 · FDA Enforcement Report
CareLink SmartSync Device Manager (24970A) recalled
Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) is recalling CareLink SmartSync Device Manager (24970A). The recall was initiated on 6 Apr 2021 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-1522-2021
- FDA event ID
- 87654
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf), Mounds View, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Apr 2021
- FDA classified
- 30 Apr 2021
- Reported
- 12 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Apr 2021 | Recall initiated by company | |
| 30 Apr 2021 | Classified by FDA | +24 days |
| 12 May 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
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
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Where it was distributed
Worldwide
Questions about this recall
Why was it recalled?
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
Which lots are affected?
All serial numbers
Where was it sold?
Worldwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87654| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Crt-p Quad recalled by Medtronic Inc., Cardiac | Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) | Device Malfunction | MN |
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