Z-2327-2025Class I

RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator...

Name: Z-2327-2025 RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator...
Creator: Boston Scientific Corporation
Published: 2025-07-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-07-24 / Open, Classified / root cause: design

FDA source

Boston Scientific Corporation began a recall of RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682... on 2025-07-24. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2327-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-07-24
Posted: 2025-08-20
Recalling firm: Boston Scientific Corporation
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
Product code: NVY Permanent Defibrillator Electrodes
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 247,702 US; 344,670 OUS
Distribution: Worldwide Distribution. US nationwide. International distribution worldwide.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2327-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2325-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-20
Z-2326-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-20
Z-2327-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-20

Product code NVY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)