FDAFDA · Food and drugs·Recall number Z-2147-2014
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.
Published August 13, 2014 · Recall initiated: June 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific CRM Corp
- Distributor
- Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
- Lot
- Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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