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

Reliance 4-Front, endocardial cardioversion/defibrillation recalled

Boston Scientific is recalling Reliance 4-Front, endocardial cardioversion/defibrillation and pace/sense lead, Permanent, 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 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

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-2327-2025
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

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

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 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

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	Endotak Reliance G/SG, transvenous defibrillation lead recalled	Boston Scientific	Other	Nationwide

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