Events

Recall of Device Recall ISOMED refill kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Neuromodulation.

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
    47755
  • Event Risk Class
    Class 2
  • Event Number
    Z-1903-2008
  • Event Initiated Date
    2008-02-04
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70072
  • 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
    Programmable, Implanted, Infusion Pump - Product Code LKK
  • Reason
    Medtronic is retrieving all unused packages of isomed refill kit model 8553, lot 60538731. this lot of product was released using incorrect endotoxin specification limits. endotoxin contamination can potentially lead to fever, malaise, respiratory distress, septic shock, and death.
  • Action
    Consignees were notified by Medtronic field personnel, either by personal visits or telephone, beginning 2/4/08. This included the 8 additional consignees located outside of the U.S. Medtronic advised customers not to use any unused packages in their inventory and that a field representative would assist them in returning the product for replacement and/or credit. Upon completion of each follow-up, the field representatives completed and returned a Reply Card documenting the notification. If you have questions or comments, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Device

Device Recall ISOMED refill kit
  • Model / Serial
    Lot 60538731, Use by Date is May 10, 2009.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide -- including the U.S. (AK, AL, AR, AZ, CA, CT, DC,DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV) and Argentina, Australia, and Hong Kong.
  • Product Description
    IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10-ml syringe, 60-ml lidded syringe, Fenestrated drape, Template; Use by Date May 10, 2009; Medtronic, Inc., Minneapolis, MN. Product is packaged in a sterile container.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Manufacturer Address
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA