Events

Recall of Device Recall Synchromed II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc, Neurological & Spinal Division.

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
    29297
  • Event Risk Class
    Class 2
  • Event Number
    Z-1040-04
  • Event Initiated Date
    2004-05-11
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33489
  • 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
    Pump, Infusion - Product Code FRN
  • Reason
    The opposite version serial numbers were assigned to 20ml and 40ml synchromed ii model 8637 pumps. this size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 ml pump and could cause some confusion related to the size of a 20 ml pump which identifies itself as a 40 ml pump.
  • Action
    The physicians have been notified via letter of the problem with the pump. Appointments will be made with the patients and a Medtronic representative to correct the implanted devices.

Device

Device Recall Synchromed II
  • Model / Serial
    Serial numbers: NGP002428N, NGP002429N, NGP002430N, NGP002436N, NGP002437N, NGP002447N, NGP002448N, NGP002495N, NGV001296N, NGV001335N, NGV001390N, NGV001391N, NGV001433N, NGV001447N
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Within the United States and outside the United States.
  • Product Description
    Synchromed II infusion pump
  • Manufacturer
    Medtronic Inc, Neurological & Spinal Division

Manufacturer

Medtronic Inc, Neurological & Spinal Division
  • Manufacturer Address
    Medtronic Inc, Neurological & Spinal Division, 800 53rd Ave Ne, Columbia Heights MN 55421-1241
  • Source
    USFDA