Z-1526-2021 Class II Ongoing
FDA device recall Z-1526-2021 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on April 6, 2021 and is designated Class II. Reason for recall: 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 dev… The recall status is ongoing. Affected quantity: 333408 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 12, 2021
- Initiation Date
- April 6, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 333408 units
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.
Reason for Recall
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 Pattern
Worldwide distribution.
Code Information
all codes