Boston Scientific ENDOTAK RELIANCE¿ SG — Class II medical device recall Z-2147-2014
Terminated recall by Boston Scientific CRM Corp, reported 2014-08-13, distributed nationwide. A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a sus
| Recall number | Z-2147-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific CRM Corp, Saint Paul, MN, United States |
| Recall initiated | 2014-06-19 |
| Classified | 2014-08-04 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2014-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 21 |
| Model numbers | 0180, 0292, 130450, 309339, 310735, 310892 |
Product
Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.
Reason for recall
A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2147-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.