Class II — Boston Scientific CRM Corp
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 21 |
| Distribution | Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France |
| Initiated | 2014-06-19 |
| Classified | 2014-08-04 |
| Terminated | 2014-12-03 |
| Recall number | Z-2147-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific CRM Corp (Z-2147-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68700/
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