Boston Scientific Pacemakers Software Issue Can Trigger Inappropriate Safety Mode
Boston Scientific is recalling certain ACCOLADE family pacemakers, including ALTRUA 2 models, because a software issue can cause inappropriate Safety Mode activation in ambulatory settings. A software update is available to prevent this malfunction.
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 FDA Class I recall of cardiac pacemakers meets the regulatory minimum threshold of Severe based on the agency classification. Although no deaths or serious injuries have been reported, the risk involves potential device malfunction that could affect patient safety.
Plain-English summary
Boston Scientific Corporation is recalling certain pacemakers from the ACCOLADE family, including the ALTRUA 2 DR EL, ACCOLADE, PROPONENT, and ESSENTIO models, as well as VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers. A total of 3,376 units have been distributed worldwide.
The identified issue involves affected devices potentially initiating Safety Mode inappropriately when detecting high battery impedance, even when patients are in ambulatory settings outside hospital monitoring. Safety Mode activation in these circumstances represents a safety concern for patients.
To address this issue, Boston Scientific has released a software update designed to prevent inappropriate Safety Mode initiation caused by high battery impedance conditions. Patients who believe they have one of the affected devices should contact their healthcare provider to confirm their device status and to schedule the software update if needed.
The recalled product
- Product
- Model Number S722, ALTRUA 2 DR EL Pacemaker
- Manufacturer
- Boston Scientific Corporation
- Hazard
- software-defect
- 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)
- GTIN 00802526559372
- Serial numbers: 100037
- 100039
- 100040
- 100041
- 100042
- 100052
- 100066
- 100067
- 100068
- 100070
- 100071
- 100072
- 100073
- 100075
- 100076
- 100077
- 100080
- 100081
- 700442
Distribution
Distribution scope not specified by the agency.
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