ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous… recallZ-2326-2025 · Boston Scientific Corporation · initiated Jul 24, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Component design/selection
What the company 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.
Recall details
- Recall number
- Z-2326-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 24, 2025
- Posted by the FDA
- Aug 20, 2025
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 247,702 US; 344,670 OUS
- Product code
- NVY
- FDA submissions
- P910073
- Distribution
- Worldwide Distribution. US nationwide. International distribution worldwide.
Product description
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
Code information (models, lots, serial numbers)
Model 0282 UDI-DI/GTIN 00802526431371; Model 0283 UDI-DI/GTIN 00802526431388 00802526504181; Model 0285 UDI-DI/GTIN 00802526431401; Model 0286 UDI-DI/GTIN 00802526431418; Model 0292 UDI-DI/GTIN 00802526431432 00802526474668 00802526480096 00802526485763 00802526504396 00802526531248 00802526541742 00802526552441 00802526611186; Model 0293 UDI-DI/GTIN 00802526431449 00802526531255 00802526541827 00802526552526 00802526554490 00802526611179; Model 0295 UDI-DI/GTIN 00802526431463 00802526474699 00802526531262 00802526541902 00802526554506 00802526611131; Model 0296 UDI-DI/GTIN 00802526431470 00802526474705 00802526480164 00802526480188 00802526531279 00802526541988 00802526552038
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- ENDOTAK RELIANCE® G 0295Boston Scientific Corporation · Permanent defibrillator electrodes1 recall9 deaths1,070 reports
- ENDOTAK RELIANCE® G 0296Boston Scientific Corporation · Permanent defibrillator electrodes1 recall4 deaths862 reports
- ENDOTAK RELIANCE® SG 0282Boston Scientific Corporation · Permanent defibrillator electrodes1 recall95 reports
- ENDOTAK RELIANCE® G 0285Boston Scientific Corporation · Permanent defibrillator electrodes1 recall1 death92 reports
- ENDOTAK RELIANCE® G 0286Boston Scientific Corporation · Permanent defibrillator electrodes1 recall83 reports
- ENDOTAK RELIANCE® SG 0283Boston Scientific Corporation · Permanent defibrillator electrodes1 recall1 death49 reports
Product lines
Other devices under the same FDA submission
42 devices cleared under P910073 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ENDOTAK RELIANCE® SG 0292Boston Scientific Corporation · Permanent defibrillator electrodes16 deaths3,197 reports
- RELIANCE 4-FRONT™ 0672Boston Scientific Corporation · Permanent defibrillator electrodes13 deaths2,895 reports
- RELIANCE 4-FRONT™ 0673Boston Scientific Corporation · Permanent defibrillator electrodes10 deaths2,173 reports
- ENDOTAK RELIANCE® SG 0293Boston Scientific Corporation · Permanent defibrillator electrodes8 deaths2,039 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- ENDOTAK RELIANCE® G 0184Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths838 reports
- ENDOTAK RELIANCE® SG 0181Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)3 deaths651 reports
- ENDOTAK RELIANCE® S 640272-103Boston Scientific Corporation · Permanent defibrillator electrodes3 deaths516 reports
- ENDOTAK RELIANCE® SG 0180Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 deaths436 reports
- ENDOTAK RELIANCE® S 640273-103Boston Scientific Corporation · Permanent defibrillator electrodes2 deaths391 reports
- ENDOTAK RELIANCE® G 0175Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall5 deaths314 reports
- ENDOTAK RELIANCE® 0158Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 death331 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97318).
- Z-2325-2025 · Open, ClassifiedENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o18…
- Z-2327-2025 · Open, ClassifiedRELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692,…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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