Boston Scientific Corporation recalls ENDOTAK RELIANCE G/SG
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- 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 00802…Show all
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
Show 30 more code fieldsShow fewer
What the firm is doing
On July 24, 2025, firm notified physicians via Important Medical Device Information letters. The letter provides information on the management of gradually rising daily subthreshold, low-voltage shock impedance (LVSI) pattern associated with calcification of expanded polytetrafluoroethylene (ePTFE) coated single coil (SC) and dual coil (DC) RELIANCE defibrillation leads manufactured by Boston Scientific Corporation between 2002 to 2021. Letter includes recommendations for routine follow-ups of affected leads, and considerations to take if lead replacement is planned. The firm is not recommending any changes to the scheduled follow-up interval for patients with ePTFE lead models.
DistributionShow detailsHide
Worldwide Distribution. US nationwide. International distribution worldwide.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2325-2025
- FDA device classification · LWSOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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