The Recall Desk
SevereFDA (Devices)·Z-2019-2021·Announced 2021-07-21

INTUA CRT-P Pacemakers Recalled Due to Battery Degradation Risk

The INTUA CRT-P pacemakers (1,707 units) may develop high internal battery impedance later in device life, causing system resets and triggering Safety Mode. Therapy continues but device replacement is required.

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: This is an FDA Class I device recall, which requires a minimum severity score of 4 per the rubric. Although no deaths or serious injuries are reported in the source text, the defect affects critical life-support devices and necessitates replacement.

Plain-English summary

Boston Scientific is recalling 1,707 INTUA CRT-P dual chamber pacemakers (Models V272, V273, W273) built with Extended Life (EL) batteries. These cardiac resynchronization therapy devices may develop high internal battery impedance later in their service life, prior to reaching the normal end-of-life indicator.

High battery impedance can cause temporary system resets triggered by high-power telemetry attempts. When resets occur, the device may revert to Safety Mode—a backup pacing function that preserves battery life. Although pacing therapy continues in Safety Mode, device replacement is required.

Patients with affected devices should contact their healthcare provider. The recalled devices were distributed worldwide.

The recalled product

Product
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Manufacturer
Boston Scientific Corporation
Hazard
  • battery-degradation
  • system-reset
  • mode-change

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) V272
  • Serial Numbers: 100002
  • 100014
  • 100017
  • 100021
  • 100028
  • 100037
  • 100048
  • 100052
  • 100053
  • 100054
  • 100065
  • 100067
  • 100068
  • 100075
  • 100077
  • 100080
  • 100092
  • 100093
  • 100096

Distribution

Distribution scope not specified by the agency.