ENDOTAK RELIANCE G/SG with 4-SITE Connector recall
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286…
Why was ENDOTAK RELIANCE G/SG with 4-SITE Connector recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 247,702 US; 344,670 OUS
- Distribution
- Worldwide Distribution. US nationwide. International distribution worldwide.
- Recall date
- August 27, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)