Agency classClass IOur severity:Severe FDA (Devices)·Z-2020-2021·Announced 2021-07-21

Boston Scientific INLIVEN CRT-P Pacemakers Battery Impedance Recall

Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.

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 minimum severity score of 4. Although no illnesses or injuries have been reported, the latent battery malfunction poses inherent patient safety risk through potential system resets, even with maintained backup pacing capability.

Plain-English summary

Boston Scientific Corporation is recalling certain dual chamber INGENIO family pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) with Extended Life batteries. The affected models are V284, V285, W274, and W275, with approximately 3,634 units distributed worldwide.

These devices may initiate Safety Mode later in their operational lifespan, before the battery reaches the explant indicator. This occurs when the device's battery develops high internal impedance. This latent condition creates a risk for system resets due to temporary high-power consumption from telemetry attempts, after which the device reverts to Safety Mode to maintain backup pacing.

Although therapy is still provided when a device is in Safety Mode, replacement of the device is required. The recall affects only dual chamber INGENIO family models with the Extended Life battery design.

The recalled product

Product: INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Pacemaker
Hazard: battery-impedance
system-reset
pacemaker-malfunction
Affected units: 3,634

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) V284
Serial Numbers: 100002
100000
100003
100005
100009
100010
100011
100012
100014
100015
100016
100017
100018
100019
100022
100023
100027
100029
234350

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 →

Same manufacturer · Boston Scientific Corporation

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Same hazard · battery impedance