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.
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: 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
- Hazard
- battery-malfunction
- 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) 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.
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