The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0827-2025·Announced 2025-01-22

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.

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 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
Category
Medical Device — Cardiac Pacemakers
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)

  • 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.

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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