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Boston Scientific CRM Corp recalls Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Recalled August 28, 2013 · FDA recall Z-1979-2013 · Boston Scientific CRM
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 · FDA Class II
Units
1 (4 devices were implanted and are not part of this action)
Sold at
US distribution in the state of Tennessee.
Description
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
Product
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Manufacturer(s)
Boston Scientific CRM Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →