Boston Scientific Corporation recalls RELIANCE 4-FRONT
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- Model
- 0657
- UDI
- 00802526560934
- Model
- 0682
- UDI
- 00802526560958
- Model
- 0683
- UDI
- 00802526560965
- Model
- 0685
- UDI
- 00802526560972
- Model
- 0686
- UDI
- 00802526560989
- Model
- 0692
- UDI
- 00802526519017 00802526560996 00802526568664 00802526568688
- Model
- 0693
- UDI
- 00802526518850 00802526519055 00802526537769 00802526561009 00802526568701
- Model
- 0695
- UDI
- 00802526519093 00802526561016
- Model
- 0696
- UDI
- 00802526519987 00802526561207 00802526568831
Show 8 more code fieldsShow fewer
What the firm is doing
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.
DistributionShow detailsHide
Worldwide Distribution. US nationwide. International distribution worldwide.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2327-2025
- FDA device classification · NVYOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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