VISIONIST CRT-P Pacemakers Recalled Due to Battery Impedance Risk
Certain VISIONIST CRT-P pacemakers with latent high battery impedance may initiate Safety Mode unexpectedly during normal operations. Manufactured before September 2018, 156,329 units were distributed worldwide.
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 classification requires a minimum severity of Severe per the rubric. The recall involves potential unintended device behavior in a critical cardiac device, though no injuries or illnesses have been reported.
Plain-English summary
Boston Scientific's VISIONIST CRT-P pacemakers (models U225, U226, and U228) are subject to a Class I recall. These devices contain latent high battery impedance that creates an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations.
The recall affects devices manufactured before September 2018. A total of 156,329 units were distributed: 59,937 in the United States (including Puerto Rico and US Virgin Islands) and 96,792 outside the US (to Guam and Northern Mariana Islands).
Patients with these pacemakers should contact their healthcare provider to verify whether their device is affected based on the model and serial number.
The recalled product
- Product
- VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
- Manufacturer
- Boston Scientific Corporation
- Hazard
- high-battery-impedance
- device-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)
- U225 - UDI-DI: 00802526559433
- 00802526577116
- 00802526577048
- 00802526578809
- U226 - UDI-DI: 00802526559457
- 00802526559464
- 00802526577062
- 00802526577123
- U228 - UDI-DI: 00802526577130
- 00802526559488
- 00802526578830
Distribution
Distributed nationwide across the United States.
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