Pacemakers and CRT devices require software update for battery safety
Boston Scientific is recalling 3,620 pacemakers and CRT devices worldwide. The software update prevents inappropriate Safety Mode initiation due to high battery impedance.
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 classification requires a minimum severity score of 4 per the rubric. Although no deaths or serious injuries are reported in the source, the potential for device malfunction affecting a critical life-sustaining implanted device warrants this level.
Plain-English summary
Boston Scientific Corporation is recalling 3,620 cardiac pacemaker and cardiac resynchronization therapy pacemaker (CRT-P) devices distributed worldwide, including models from the ACCOLADE family, VISIONIST, and VALITUDE devices.
The issue involves a potential for Safety Mode to be inappropriately initiated in an ambulatory setting when devices experience high battery impedance. Boston Scientific has developed software designed to enhance the Safety Architecture and prevent this unintended mode initiation.
Affected patients should contact Boston Scientific or their healthcare provider regarding availability of the software update.
The recalled product
- Product
- Model Number U125, VALITUDE CRT-P EL
- Manufacturer
- Boston Scientific Corporation
- Hazard
- safety-mode-malfunction
- battery-impedance-issue
- software-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 00802526559389
- Serial numbers: 100095
- 100182
- 100194
- 100221
- 100236
- 100239
- 100242
- 100243
- 100247
- 100254
- 100258
- 100259
- 100263
- 100270
- 100285
- 100287
- 100292
- 100298
- 100301
Distribution
Distribution scope not specified by the agency.
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