The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-0103-2026·Announced 2025-10-22

Cardiac resynchronization pacemakers recalled for Safety Mode software architecture update

Boston Scientific is recalling 12,326 VISIONIST CRT-P EL devices, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.

Plain-English summary

The VISIONIST CRT-P EL cardiac resynchronization therapy pacemaker, model U225, is covered by a recall in which software to enhance Safety Architecture is made available.

The software is designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state. It applies to the ACCOLADE family of devices, which includes ACCOLADE, PROPONENT, ESSENTIO and ALTRUA 2 dual chamber standard life and extended life pacemakers, and to VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers.

The recall covers 12,326 units carrying GTIN 00802526559426, distributed worldwide. The FDA has classified the recall as Class I.

Patients and clinicians should follow Boston Scientific's instructions for obtaining the software update at a device follow-up appointment.

The recalled product

Product
Model Number U225 VISIONIST CRT-P EL
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Pacemaker
Hazard
Affected units
12,326

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)

  • GTIN 00802526559426
  • Serial numbers: 709683
  • 709711
  • 709737
  • 709778
  • 709780
  • 709789
  • 709792
  • 709794
  • 709804
  • 709815
  • 709816
  • 709827
  • 709828
  • 709829
  • 709830
  • 709831
  • 709889
  • 709907
  • 709912

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 27 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 27 products in this recall →

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