The Recall Desk
HighFDA (Devices)·Z-2003-2021·Announced 2021-07-14

VISIONIST CRT-P Pacemaker Recalled Due to Battery Depletion Risk

Boston Scientific has recalled 5,920 VISIONIST CRT-P pacemakers due to hydrogen gas buildup that can compromise a capacitor and cause accelerated battery depletion. Affected patients should contact their healthcare provider for device evaluation.

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: This is an FDA Class II recall of a critical medical device involving a manufacturing defect that could compromise device function. While no deaths or hospitalizations are reported, this is a risk-of-harm product (pacemaker) where premature battery depletion could lead to serious patient harm if not detected and addressed through the device's warning indicators.

Plain-English summary

Boston Scientific Corporation has recalled 5,920 VISIONIST CRT-P cardiac resynchronization therapy pacemakers worldwide. The recall affects three specific models: U225, U226, and U228.

The devices are being recalled due to a manufacturing defect involving hydrogen gas. Small amounts of hydrogen may build up inside the pacemaker over time, potentially compromising the electrical function of a low-voltage capacitor. This compromise can result in accelerated battery depletion and progression of the battery depletion warning indicators displayed to patients and healthcare providers.

Patients who have received one of the affected VISIONIST CRT-P pacemakers should contact their healthcare provider or Boston Scientific to determine if their specific device is included in the recall.

Patients should not attempt to remove or disable their device. Instead, they should work with their healthcare provider to arrange appropriate clinical follow-up and device evaluation to assess the need for device replacement or monitoring.

The recalled product

Product
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiac Pacemaker
Hazard
Affected units
5,920

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 (20)

  • a) U225
  • Serial Numbers: 707340
  • 100094
  • 100142
  • 100152
  • 100160
  • 100184
  • 100309
  • 100364
  • 100807
  • 100880
  • 100908
  • 100913
  • 700015
  • 700197
  • 700469
  • 700559
  • 700563
  • 700576
  • 700586

Distribution

Distribution scope not specified by the agency.

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 →

Related recalls

Same manufacturer · Boston Scientific Corporation

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Same hazard · battery depletion

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