FDAFDA · Food and drugs·Recall number Z-1979-2013
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Published August 28, 2013 · Recall initiated: July 15, 2013
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
Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufactu
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific CRM Corp
- Distributor
- US distribution in the state of Tennessee.
- Lot
- Serial # 108063
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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