Events

Recall of St Jude Medical Ellipse DR CD2377-36 Implantable Defibrillator

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by St Jude Medical (USA).

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
    17202
  • Event Initiated Date
    2014-08-19
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Reason
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Action
    Manufacturer to issue advice regarding use

Device

St Jude Medical Ellipse DR CD2377-36 Implantable Defibrillator
  • Model / Serial
    Model: Model: DR CD2377-36, Affected: Ellipse ICDs with serial numbers beginning with “1” and that are below 1131098, as well as Ellipse ICDs with serial numbers beginning with “7” that are below 7127327
  • Manufacturer
    St Jude Medical (USA)

Manufacturer

St Jude Medical (USA)
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA