Recall Z-2327-2025
Boston Scientific Corporation · initiated July 24, 2025
Class I – dangerous or defective products that could cause serious health problems or death
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
Codes / lots: 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
Reason for recall
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.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-2327-2025
- Initiated
- July 24, 2025
- Posted by FDA
- August 20, 2025
- Product code
- NVY – Permanent Defibrillator Electrodes
- Quantity
- 247,702 US; 344,670 OUS
- Distribution
- Worldwide Distribution. US nationwide. International distribution worldwide.
- Recalling firm
- Boston Scientific Corporation, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2325-2025 Class I | ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | 07/24/2025Open, Classified |
| Z-2326-2025 Class I | ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | 07/24/2025Open, Classified |