Boston Scientific Pacemakers Software Update for Safety Mode
Boston Scientific is issuing a software update for multiple pacemaker models to prevent unwanted Safety Mode activation due to high battery impedance in ambulatory settings. The update affects ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE models distributed worldwide.
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 medical device recall. Per the rubric, FDA Class I recalls have a minimum score of 4. No deaths or injuries have been reported in the source material.
Plain-English summary
Boston Scientific Corporation is recalling a software issue affecting multiple pacemaker models. A software update is available to prevent unwanted initiation of Safety Mode in ambulatory settings when high battery impedance conditions occur.
The recall affects 41,009 units worldwide of the following Boston Scientific pacemaker models: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 (dual chamber), VISIONIST, and VALITUDE. These include standard life and extended life variants, as well as cardiac resynchronization therapy pacemakers.
Patients with affected pacemakers should contact their healthcare provider or Boston Scientific to receive the software update. The update is designed to prevent Safety Mode from being triggered inappropriately when high battery impedance is detected in ambulatory patients.
The recalled product
- Product
- Model Number L210 PROPONENT SR SL Pacemaker
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Hazard
- software-defect
- safety-mode-malfunction
- battery-impedance
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 00802526559082
- Serial Numbers: 100002
- 100009
- 100010
- 100011
- 100012
- 100014
- 100017
- 100020
- 100021
- 100023
- 100024
- 100026
- 100029
- 100034
- 100037
- 100038
- 100040
- 100041
- 100045
Distribution
Distribution scope not specified by the agency.
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