Reliance 4-Front Lead (Boston Scientific) – Measurement Problem (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Model 0657 UDI-DI 00802526560934, Model 0682 UDI-DI 00802526560958, Model 0683 UDI-DI 00802526560965, Model 0685 UDI-DI 00802526560972, Model 0686 UDI-DI 00802526560989, Model 0692 UDI-DI 00802526519017 00802526560996 00802526568664 00802526568688, Model 0693 UDI-DI 00802526518850 00802526519055 00802526537769 00802526561009 00802526568701, Model 0695 UDI-DI 00802526519093 00802526561016, Model 0696 UDI-DI 00802526519987 00802526561207 00802526568831
Products Sold
Model 0657 UDI-DI 00802526560934; Model 0682 UDI-DI 00802526560958; Model 0683 UDI-DI 00802526560965; Model 0685 UDI-DI 00802526560972; Model 0686 UDI-DI 00802526560989; Model 0692 UDI-DI 00802526519017 00802526560996 00802526568664 00802526568688; Model 0693 UDI-DI 00802526518850 00802526519055 00802526537769 00802526561009 00802526568701; Model 0695 UDI-DI 00802526519093 00802526561016; Model 0696 UDI-DI 00802526519987 00802526561207 00802526568831
Boston Scientific Corporation is recalling RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrilla due to Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On July 24, 2025, firm notified physicians via Important Medical Device Information letters. The letter provides information on the management of gradually rising daily subthreshold, low-voltage shock impedance (LVSI) pattern associated with calcification of expanded polytetrafluoroethylene (ePTFE) coated single coil (SC) and dual coil (DC) RELIANCE defibrillation leads manufactured by Boston Scientific Corporation between 2002 to 2021. Letter includes recommendations for routine follow-ups of affected leads, and considerations to take if lead replacement is planned. The firm is not recommending any changes to the scheduled follow-up interval for patients with ePTFE lead models.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026