Home / Recalls / Boston Scientific CRM Corp / Z-1979-2013

Z-1979-2013 Class II Terminated

Recalled by Boston Scientific CRM Corp — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
August 28, 2013
Initiation Date
July 15, 2013
Termination Date
November 12, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 (4 devices were implanted and are not part of this action)

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

Distribution Pattern

US distribution in the state of Tennessee.

Code Information

Serial # 108063

Other recalls by Boston Scientific CRM Corp

  • Z-0088-2015 Class II — Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, (September 17, 2014)
  • Z-0087-2015 Class II — Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, (September 17, 2014)
  • Z-2147-2014 Class II — Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models (June 19, 2014)
  • Z-0026-2014 Class II — Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, (August 29, 2013)
  • Z-0025-2014 Class II — Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, (August 29, 2013)
  • Z-1339-2013 Class II — LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Pa (April 10, 2013)
  • Z-0965-2013 Class II — Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. (March 1, 2013)