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U.S. Department of Health and Human Services

Class 1 Device Recall ENDOTAK RELIANCE G/SG

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 Class 1 Device Recall ENDOTAK RELIANCE G/SGsee related information
Date Initiated by FirmJuly 24, 2025
Date PostedAugust 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2325-2025
Recall Event ID 97318
PMA NumberP910073 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
ProductENDOTAK 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 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
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information ContactUnited States Technical Services
800-227-3422
Manufacturer 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 2		Component design/selection
ActionOn 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 Commerce247,702 US; 344,670 OUS
DistributionWorldwide Distribution. US nationwide. International distribution worldwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LWS
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