Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
This recall has been terminated (originally issued August 16, 2013).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- July 15, 2013
- Posted
- August 16, 2013
- Terminated
- November 12, 2013
- Recall Number
- Z-1979-2013
- Quantity
- 1 (4 devices were implanted and are not part of this action)
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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
Distribution
US distribution in the state of Tennessee.
Lot / Code Info
Serial # 108063
Root Cause
Under Investigation by firm
Action Taken
Consignee was sent on 7/15/13 a Boston Scientific "Medical Device Retrieval" letter dated July 12. 2013. The letter described the product problem and informed the consignee that they will replace the product removed from their inventory. For further questions, contact Boston Scientific Technical Services at 1 800 227-3422.