ENDOTAK RELIANCE G/SG, transvenous defibrillation lead… recallZ-2325-2025 · 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-2325-2025
- 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
- LWS
- FDA submissions
- P910073
- Distribution
- Worldwide Distribution. US nationwide. International distribution worldwide.
Product description
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
Model 0161 UDI-DI/GTIN 00802526372766; Model 0164 UDI-DI/GTIN N/A; Model 0165 UDI-DI/GTIN 00802526377259; Model 0167 UDI-DI/GTIN N/A 00802526373251; Model 0170 UDI-DI/GTIN 00802526373282 00802526373299; Model 0171 UDI-DI/GTIN 00802526373374 00802526373381; Model 0172 UDI-DI/GTIN 00802526373466; Model 0173 UDI-DI/GTIN 00802526373558 00802526373565; Model 0174 UDI-DI/GTIN 00802526373640; Model 0175 UDI-DI/GTIN 00802526373732 00802526373749; Model 0176 UDI-DI/GTIN 00802526376726 00802526376733; Model 0177 UDI-DI/GTIN 00802526376818 00802526376825; Model 0180 UDI-DI/GTIN 00802526411977 00802526422027 00802526433597 00802526531149 00802526540943 00802526540950 00802526591518; Model 0181 UDI-DI/GTIN 00802526411984 00802526422034 00802526433689 00802526433726 00802526433757 00802526491009 00802526502903 00802526531156; Model 0182 UDI-DI/GTIN 00802526422041 00802526531163; Model 0183 UDI-DI/GTIN 00802526422058 00802526531170; Model 0184 UDI-DI/GTIN 00802526412011 00802526422065 00802526433986 00802526433993 00802526491313 00802526531187 00802526541261 00802526583438; Model 0185 UDI-DI/GTIN 00802526412028 00802526413438 00802526422072 00802526434082 00802526434099 00802526434105 00802526434150 00802526434174 00802526470622 00802526491405 00802526491412 00802526491429 00802526503306 00802526531194 00802526541346 00802526591563 00802526612541; Model 0186 UDI-DI/GTIN 00802526412035 00802526422089 00802526434198 00802526531200; Model 0187 UDI-DI/GTIN 00802526412042 00802526422096 00802526531217
Devices named in this recall
7 devices in the FDA device registry whose identifier appears in the recall's code information.
- ENDOTAK RELIANCE® G 0175Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall5 deaths314 reports
- ENDOTAK RELIANCE® G 0174Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall112 reports
- ENDOTAK RELIANCE® SG 0171Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall41 reports
- ENDOTAK RELIANCE® SG 0170Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall19 reports
- ENDOTAK RELIANCE® G 0187Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall8 reports
- ENDOTAK RELIANCE® G 0176Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall2 reports
- ENDOTAK RELIANCE® G 0177Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall0 reports
Product lines
Other devices under the same FDA submission
41 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 0295Boston Scientific Corporation · Permanent defibrillator electrodes1 recall9 deaths1,070 reports
- ENDOTAK RELIANCE® G 0296Boston Scientific Corporation · Permanent defibrillator electrodes1 recall4 deaths862 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
Other products in the same recall event
The FDA groups related products into one recall event (event 97318).
- Z-2326-2025 · Open, ClassifiedENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
- 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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