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.
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: 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
- Affected units
- 1,707
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.
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.
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