Boston Scientific Recalls ACCOLADE Family Pacemakers for Safety Mode Software Defect
Boston Scientific is recalling ACCOLADE pacemakers due to a software defect that may cause unintended Safety Mode activation when battery impedance is elevated. A software update is available to address this issue.
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 medical device recall. Per the severity rubric, FDA Class I recalls must score no lower than 4 (Severe), regardless of whether injuries have been reported. The source does not state reported illnesses or injuries.
Plain-English summary
Boston Scientific Corporation is recalling ACCOLADE SR SL (Model L300) pacemakers distributed worldwide. The recall also affects other models in the ACCOLADE family, including ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber pacemakers, as well as VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers. Approximately 16,077 units have been distributed globally.
These devices have a software defect that may cause Safety Mode to initiate unexpectedly in ambulatory settings when the device detects a high battery impedance state.
Boston Scientific has made available enhanced software designed to prevent Safety Mode from initiating due to the high battery impedance condition. Patients should contact their healthcare provider or Boston Scientific to obtain the software update for their device.
The FDA classified this as a Class I recall.
The recalled product
- Product
- ACCOLADE SR SL (Model L300)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Hazard
- software-defect
- safety-mode-malfunction
- battery-impedance-issue
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)
- GTIN 00802526558900
- Serial Numbers: 464190
- 464192
- 464197
- 464228
- 464229
- 464230
- 464238
- 464258
- 464279
- 464295
- 464296
- 464316
- 464321
- 464358
- 464360
- 464361
- 464362
- 464363
- 464369
Distribution
Distribution scope not specified by the agency.
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