The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0826-2025·Announced 2025-01-22

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category
Medical Device — Pacemaker / CRT-P
Hazard

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.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Boston Scientific Corporation 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.

See all 6 products in this recall →

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