Recall Z-2147-2014— Boston Scientific CRM Corp
Class II · Terminated
Class II FDA medical device recall by Boston Scientific CRM Corp, initiated 2014-06-19, terminated 2014-12-03. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Boston Scientific CRM Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-19
- Terminated
- 2014-12-03
- Firm location
- Saint Paul, MN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.