Boston Scientific CRM Corp: Medical Device Recall in 2013 - (Recall #: Z-1979-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 15, 2013

Date Posted: August 28, 2013

Recall Number: Z-1979-2013

Event ID: 65798

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

Status: Terminated

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

Code Information:

Serial # 108063

Distribution Pattern:

US distribution in the state of Tennessee.

Voluntary or Mandated:

Voluntary: Firm initiated