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

Endotak Reliance G/SG with 4-Site Connector recalled

Boston Scientific is recalling Endotak Reliance G/SG with 4-Site Connector, transvenous defibrillation 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 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

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-2326-2025
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 with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296

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 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

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

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025	CLASS I	Reliance 4-Front, endocardial cardioversion/defibrillation 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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