Accolade Pacemakers Recalled for Hydrogen-Related Battery Depletion
Boston Scientific is recalling Accolade pacemaker models L300, L301, L310, L311, L321, and L331 due to latent hydrogen release that compromises the capacitor and accelerates battery depletion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a life-critical device with a defect that could lead to premature device failure. No injuries or hospitalizations reported, but pacemakers are inherently risk-of-harm products where any malfunction is serious, fitting the High severity criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Boston Scientific Corporation is recalling the Accolade pacemaker in models L300, L301, L310, L311, L321, and L331. Approximately 70,074 units were distributed worldwide.
The recall addresses a defect in which latent hydrogen may accumulate within the pacemaker, potentially causing the low voltage capacitor to become electrically compromised. This compromise can result in accelerated battery depletion and faster progression of the displayed battery status indicators.
No injuries or illnesses have been reported in connection with this defect. Patients with these pacemaker models should consult their healthcare provider regarding their specific device.
The recalled product
- Product
- Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
- Manufacturer
- Boston Scientific Corporation
- Hazard
- hydrogen-buildup
- capacitor-compromise
- battery-depletion
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) L300
- Serial Numbers: 712118
- 713277
- 713352
- 713357
- 713365
- 713381
- 713390
- 713398
- 713403
- 713405
- 713406
- 713420
- 713440
- 713443
- 713447
- 713454
- 713456
- 713459
- 713461
Distribution
Distribution scope not specified by the agency.
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