The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2015-2021·Announced 2021-07-21

Boston Scientific ADVANTIO DR EL Pacemakers Recalled for Battery Malfunction

Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, 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 mandates a minimum severity score of 4. The recall addresses a latent battery defect in implanted pacemakers that may cause unpredictable system resets later in device life. Although Safety Mode preserves basic pacing functionality, the risk of device malfunction in a critical cardiac device requires mandatory replacement.

Plain-English summary

Boston Scientific Corporation is recalling ADVANTIO DR EL dual chamber pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) with Extended Life batteries. The recall affects approximately 15,717 units distributed worldwide.

The devices may develop a latent battery condition characterized by high internal impedance. This condition can cause system resets to occur later in device life, potentially before the battery reaches the Explant indicator. High-power consumption during telemetry attempts can trigger these resets and cause the device to revert to Safety Mode.

While Safety Mode continues to provide therapy, device replacement is required. Patients with an affected ADVANTIO DR EL device should contact their healthcare provider or Boston Scientific for device identification and replacement.

The recalled product

Product
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Implantable Pacemaker
Hazard
Affected units
15,717

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) J064
  • Serial Numbers: 390022
  • 390405
  • 100027
  • 100085
  • 100096
  • 100127
  • 100182
  • 100228
  • 100248
  • 100267
  • 100449
  • 100491
  • 100495
  • 100543
  • 100575
  • 100634
  • 100651
  • 100659
  • 100704

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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