Medtronic Recalls CRT-P Pacemakers Due to Longevity Estimation Error
Medtronic is recalling specific implantable cardiac resynchronization therapy pacemakers because a longevity estimation error may occur in the early years of device life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a longevity estimation error in a critical medical device, which poses a risk of harm if the device fails prematurely, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling specific implantable cardiac resynchronization therapy pacemakers (CRT-P) due to a potential longevity estimation error. The affected devices are used to treat arrhythmias related to bradycardia and provide cardiac resynchronization therapy for heart failure. The recall covers 333,408 units distributed worldwide, including models from the Percepta, Serena, and Solara families.
The issue occurs when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. This error may affect the device's longevity estimation in the early years of its life. No other device features or therapies are impacted by this defect.
Patients with these devices should contact their healthcare provider or Medtronic for guidance on monitoring and potential replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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 CR
- Category
- Medical Device — Pacemakers
- Affected units
- 333,408
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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