FDA-Device2013-08-28Class II
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Boston Scientific CRM Corp
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
Sold states
US distribution in the state of Tennessee.
Affected count
1 (4 devices were implanted and are not part of this action)
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1979-2013Don't want to check this manually?
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