Use caution Medical device recall · FDA · Published July 24, 2025

Boston Scientific Recalls ENDOTAK RELIANCE G/SG Defibrillator Leads Due to Calcification

Boston Scientific recalls ENDOTAK RELIANCE G/SG defibrillator leads with specific model numbers due to potential calcification causing early lead replacement and risk of death or cardiac resuscitation.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2326-2025Medical device Boston Scientific ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmBoston Scientific Corporation4100 Hamline Ave N · Saint Paul, MN 55112-5700

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling certain ENDOTAK RELIANCE G/SG defibrillator leads because they may calcify over time, leading to early replacement and potentially causing death or needing cardiac resuscitation. This recall affects patients with implanted defibrillators who use these specific model numbers. Read more at govinfonow.com/recall/51746-boston-scientific-recalls-endotak-reliance-g-sg-defibrillator-leads-due.

Source Summary by GovInfoNow · govinfonow.com/recall/51746-boston-scientific-recalls-endotak-reliance-g-sg-defibrillator-leads-due · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2326-2025

Cite this page

“Boston Scientific Recalls ENDOTAK RELIANCE G/SG Defibrillator Leads Due to Calcification.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51746-boston-scientific-recalls-endotak-reliance-g-sg-defibrillator-leads-due. Based on FDA recall #Z-2326-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2326-2025%22&limit=1).

The FDA announced on July 24, 2025, that Boston Scientific Corporation is recalling ENDOTAK RELIANCE G/SG with 4-SITE Connector transvenous defibrillation leads due to a Class I hazard. The affected devices may experience gradually rising LVSI measurements associated with calcification of the lead coils. This issue can lead to early lead replacement and potentially death or the need for cardiac resuscitation.

How to tell if you have it

Brand: Boston Scientific
Product: ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes
Model Nos.: 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
UPCs: 00802526431371, 00802526431388, 00802526431401, 00802526431418, 00802526431432, 00802526431449, 00802526431463, 00802526431470, 00802526504396, 00802526531248, 00802526531279, 00802526541988, 00802526554490, 00802526554506, 00802526611131
Distribution: Worldwide

The hazard

According to the FDA, 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. The most serious harm reported is death or the need for cardiac resuscitation.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls include the Imager II Angiographic Catheters Recall (Aug. 24, 2026) for tip fracture risk and the LUX-Dx Cardiac Monitor System Recall (Aug. 6, 2026) for delayed AF burden alerts. Additional recent recalls involve StoneSmart Connect Console Power Adapters (July 22, 2026), INFINION CX Lead Kits (June 17, 2026), CSK Electrodes (April 29, 2026), and Inspire Respiratory Sensing Lead Model 4340 (May 11, 2026).

How to tell if you have this one

Check the model number on the lead (0282, 0283, 0285, 0286, 0292, 0293, 0295, or 0296). The recall includes specific UDI-DI/GTIN codes listed in the product description.

Brand
Boston Scientific
Product
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Worldwide Distribution. US nationwide. International distribution worldwide.

Recall number	Product, codes & lots
Z-2325-2025	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; 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
Z-2326-2025	ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296; 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
Z-2327-2025	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; 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

Based on the official FDA remedy

What to do — step by step

Check Model Number
Identify the model number on the defibrillator lead (0282, 0283, 0285, 0286, 0292, 0293, 0295, or 0296).
Contact Your Healthcare Provider
Reach out to your doctor or cardiac care team to discuss potential lead replacement if the model is recalled.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution. US nationwide. International distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 34 days after the firm started it.

Jul 24, 2025Firm started the recall
Aug 20, 2025FDA classified it Class I
Aug 27, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51746-boston-scientific-recalls-endotak-reliance-g-sg-defibrillator-leads-due">Boston Scientific Recalls ENDOTAK RELIANCE G/SG Defibrillator Leads Due to Calcification (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2326-2025 (July 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2326-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.