CLASS I ONGOING Device recall · Reported 27 Aug 2025 · FDA Enforcement Report

Endotak Reliance G/SG, transvenous defibrillation lead recalled

Boston Scientific is recalling Endotak Reliance G/SG, transvenous defibrillation lead, implantable cardioverter, distributed nationwide in the US. The recall was initiated on 24 Jul 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel 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

Quantity recalled247,702 US; 344,670 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2325-2025
FDA event ID: 97318
Recalling firm: Boston Scientific, Saint Paul, MN
Classification: Class I
Status: Ongoing
Recall initiated: 24 Jul 2025
FDA classified: 20 Aug 2025
Reported: 27 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

24 Jul 2025	Recall initiated by company
20 Aug 2025	Classified by FDA	+27 days
27 Aug 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution. US nationwide. International distribution worldwide.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide Distribution. US nationwide. International distribution worldwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 97318

This product is part of a recall event; the main page for the event is Endotak Reliance G/SG with 4-Site Connector recalled.

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025	CLASS I	Endotak Reliance G/SG with 4-Site Connector recalled	Boston Scientific	Other	Nationwide
27 Aug 2025	CLASS I	Reliance 4-Front, endocardial cardioversion/defibrillation recalled	Boston Scientific	Other	Nationwide

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