Reported May 12, 2021 · Ongoing
CRT-P Quad Models (CRT-Ps)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
CRT-P Quad Models (CRT-Ps)
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 |
| 2 | Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 |
| 3 | Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT) |
- Lot codes and dates
- all serial numbers
- Amount recalled
- 45,411 devices
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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