FDA-Device2025-08-27Class I
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
Boston Scientific Corporation
Hazard
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Sold states
Worldwide Distribution. US nationwide. International distribution worldwide.
Affected count
247,702 US; 344,670 OUS
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2327-2025Don't want to check this manually?
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