CRT-P Pacemakers Recalled for Potential Safety Mode Initiation Risk
Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I device recall classification mandates a minimum severity score of 4 per the rubric. Although no deaths or injuries have been reported, the agency's Class I designation reflects a serious potential for adverse health consequences from the latent battery impedance defect.
Plain-English summary
Boston Scientific Corporation is recalling a subset of devices from the ACCOLADE Family of pacemakers and cardiac resynchronization therapy (CRT-P) devices, including VALITUDE CRT-P models (Model Numbers U125 and U128), due to a potential battery impedance defect. Devices manufactured before September 2018 may develop latent high battery impedance that increases the potential for Safety Mode activation during telemetry or other normal, higher-power operations.
The recall affects 156,329 units total: 59,937 distributed in the United States (nationwide, including Puerto Rico and the U.S. Virgin Islands) and 96,792 distributed internationally to Guam and the Northern Mariana Islands. Specific serial numbers and UDI-DI codes for affected units are available in the FDA recall database (Z-0826-2025).
This is a Class I recall from the FDA's Center for Devices and Radiological Health. No deaths or injuries related to this defect have been reported.
The recalled product
- Product
- VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
- Manufacturer
- Boston Scientific Corporation
- Hazard
- battery-impedance
- pacemaker-malfunction
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 (11)
- U125 - UDI-DI: 00802526559389
- 00802526559396
- 00802526577109
- 00802526578793
- 00802526577024
- U128 - UDI-DI: 00802526559402
- 00802526559419
- 00802526576522
- 00802526578120
- 00802526577031
- 00802526593284
Distribution
Distributed nationwide across the United States.
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