Reported May 12, 2021 · Ongoing
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage
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?
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. |
| 2 | Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. |
| 3 | Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan. |
- Lot codes and dates
- all codes
- Amount recalled
- 333408 units
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
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
This product could cause temporary or reversible health problems — stop using it.
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