Recall record at a glance
| Official record | Z-1526-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Report date | May 12, 2021 |
| Recall initiation date | Apr 6, 2021 |
| Quantity | 333408 units |
| Location | Mounds View, MN, United States |
Official product description
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 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.
Why the product 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.
Distribution information
Worldwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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