The Recall Desk
SevereFDA (Devices)·Z-2016-2021·Announced 2021-07-21

INGENIO DR EL Pacemakers Recalled: Defective Battery May Trigger Safety Mode

Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.

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 recall for a critical cardiac pacemaker with a latent battery defect that may cause device malfunction and system resets. Although no deaths or serious injuries have been reported and backup pacing continues in Safety Mode, the potential for device failure in a life-supporting device combined with the Class I regulatory designation warrants a Severe rating.

Plain-English summary

Boston Scientific Corporation is recalling certain INGENIO DR EL dual chamber pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) equipped with Extended Life (EL) batteries due to a potential battery defect affecting device reliability.

The affected devices may develop high internal impedance in the battery later in device life, before the battery reaches the Explant indicator. This condition can cause the device to enter Safety Mode as it attempts to manage higher power consumption related to telemetry. When Safety Mode is triggered, temporary system resets may occur.

Although backup pacing continues to function when a device is in Safety Mode, device replacement is required to restore full functionality and eliminate the risk of future device resets. The recalled devices are identified by specific model numbers (J174, J177, K174, K184, K187) and associated serial numbers listed in the FDA recall notice.

Patients with affected devices should contact their healthcare provider or Boston Scientific Corporation to determine whether their device is included in this recall and to arrange for replacement.

The recalled product

Product
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiac Pacemakers
Hazard
  • battery-impedance
  • system-reset
  • device-malfunction

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) J174
  • Serial Numbers: 100017
  • 100107
  • 100122
  • 100124
  • 100174
  • 100278
  • 100284
  • 100374
  • 100377
  • 100430
  • 100596
  • 100636
  • 100685
  • 100725
  • 101002
  • 101103
  • 101241
  • 101331
  • 101348

Distribution

Distribution scope not specified by the agency.

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