Events

Recall of Device Recall Medtronic GEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic,Inc/Rice Creek Facil.

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
    25041
  • Event Risk Class
    Class 2
  • Event Number
    Z-0308-03
  • Event Initiated Date
    2002-11-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25053
  • 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
  • Reason
    Extended charge times prior to defibrillation shock.
  • Action
    An 'Important Patient Management Information' letter, dated November 14, 2002, was sent to physicians following patients who had the defibrillators implanted and this gave recommendations to physicians to prevent the problem.

Device

Device Recall Medtronic GEM
  • Model / Serial
    All serial numbers beginning with PIM4. The serial number have the form of PIM4xxxxxx.
  • Distribution
    The devices have been distributed nationwide in the United States and worldwide. 2,151 units have been distributed in the United States, and 387 units have been distributed worldwide outside the U.S.
  • Product Description
    GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)
  • Manufacturer
    Medtronic,Inc/Rice Creek Facil

Manufacturer

Medtronic,Inc/Rice Creek Facil
  • Manufacturer Address
    Medtronic,Inc/Rice Creek Facil, 7000 Central Ave N.E., Fridley 55432
  • Source
    USFDA