Recall Z-1979-2013— Boston Scientific CRM Corp
Class II · Terminated
Class II FDA medical device recall by Boston Scientific CRM Corp, initiated 2013-07-15, terminated 2013-11-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.. Reason: 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.
- Recalling firm
- Boston Scientific CRM Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-15
- Terminated
- 2013-11-12
- Firm location
- Saint Paul, MN, United States
Product description
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.