FDA Device recall Z-2147-2014
Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANC…
- FDA Device
- Class II
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class II recall of Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANC… by Boston Scientific Crm, citing A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results wer….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2147-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-19 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific Crm |
| Distribution | US |
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
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.
Identifiers
| code_info | Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2014%22
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