Events

Recall of Device Recall ENERGEN DR ICD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific CRM Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65798
  • Event Risk Class
    Class 2
  • Event Number
    Z-1979-2013
  • Event Initiated Date
    2013-07-15
  • Event Date Posted
    2013-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120194
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    implantable cardioverter defibrillator (non-crt) - Product Code LWS
  • 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.
  • Action
    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.

Device

Device Recall ENERGEN DR ICD
  • Model / Serial
    Serial # 108063
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US distribution in the state of Tennessee.
  • Product Description
    Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA