VITALIO DR EL Pacemakers Recalled Due to Battery-Related Device Resets
Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.
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, which requires a minimum severity score of 4 per the rubric. Although no deaths or hospitalizations have been reported, the device malfunction risk and mandatory replacement justify the Severe rating.
Plain-English summary
Boston Scientific Corporation is recalling specific models of VITALIO DR EL dual-chamber pacemakers and cardiac resynchronization therapy pacemakers equipped with Extended Life batteries. The recall affects approximately 16,525 units distributed worldwide.
These devices may develop a latent battery condition characterized by high internal impedance that can emerge later in the device's operational life, even before the device battery indicator signals replacement is needed. The high internal impedance may trigger unexpected system resets during telemetry attempts and cause the device to activate Safety Mode to maintain backup pacing.
When in Safety Mode, the device continues to provide pacing therapy but in a limited capacity. Healthcare providers should contact Boston Scientific or consult recall documentation to identify affected devices based on model and serial numbers and plan for device replacement. No deaths or injuries have been reported in relation to this condition.
Patients with these pacemakers should contact their healthcare provider to determine if their device is included in this recall and discuss appropriate follow-up or replacement.
The recalled product
- Product
- VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Hazard
- battery-impedance
- device-reset
- safety-mode
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) J274
- Serial Numbers: 100000
- 100001
- 100005
- 100008
- 100009
- 100010
- 100016
- 100017
- 100019
- 100021
- 100026
- 100028
- 100031
- 100032
- 100033
- 100034
- 100036
- 100037
- 100038
Distribution
Distribution scope not specified by the agency.
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