The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2018-2021·Announced 2021-07-21

Boston Scientific INGENIO CRT-P Pacemakers Recalled for Battery Defect

Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require 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 applies due to potential loss of primary therapy from latent battery defect. While no illnesses have been reported, the risk of unexpected device malfunction in a life-sustaining cardiac device meets the criteria for Severe classification.

Plain-English summary

Boston Scientific Corporation is recalling certain INGENIO dual chamber pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) with Extended Life batteries. These devices may develop a latent battery condition characterized by high internal impedance that emerges later in device life, before the device reaches its normal end-of-life indicator.

When the battery exhibits high impedance, system resets may occur during telemetry attempts due to temporary high-power consumption. The device automatically activates Safety Mode to maintain backup pacing in response to these resets. Although pacing therapy continues during Safety Mode, the device malfunction requires replacement.

The recall affects 13,332 units distributed worldwide. Only INGENIO family pacemakers and CRT-Ps with Extended Life batteries are included in this recall. Specific serial numbers of affected devices are listed by model number in the FDA recall notice.

The recalled product

Product
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiac Pacemaker
Hazard
Affected units
13,332

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) V172
  • Serial Numbers: 100001
  • 100003
  • 100008
  • 100011
  • 100012
  • 100026
  • 100028
  • 100032
  • 100036
  • 100039
  • 100063
  • 100066
  • 100069
  • 100070
  • 100078
  • 100084
  • 100088
  • 100094
  • 100098

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 →

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