Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.

FDA device recall Z-1979-2013 · posted 2013-08-16 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LWS

Quantity affected

1 (4 devices were implanted and are not part of this action)

Distribution

US distribution in the state of Tennessee.

Date initiated

2013-07-15

Date posted

2013-08-16

Date terminated

2013-11-12

Location

Saint Paul, MN