Events

Recall of Device Recall NC Stormer Zipper MX Balloon Dilation Catheter

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

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
    29326
  • Event Risk Class
    Class 2
  • Event Number
    Z-1024-04
  • Event Initiated Date
    2004-06-08
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33552
  • 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
    Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
  • Reason
    Medical device for which sterility may be compromised because of improper seal.
  • Action
    A notice letter was sent to all 40 consignees, and phone contact is made. A physical visit to the account would be conducted to collect affected product.

Device

Device Recall NC Stormer Zipper MX Balloon Dilation Catheter
  • Model / Serial
    1) PMA # P790017/S79 2) Device Listing Number 2112641 3) Facility Registration number 2953200 4) lot codes 44DOE015, 44DOE016, 44DOE019, 44DOE022, 44DOE023, 44DOE020, 44DOE024, 44DOE025, 44DOE026, 44DOE021, 44DOE029, 44DOE032 5) Item numbers NCS2506ZP, NCS3016ZP, NCS2511ZP, NCS3516ZP, NCS3511ZP, NCS3521ZP, NCS3006ZP, NCS3011ZP, NCS2516ZP, NCS4006ZP, NCS4011ZP, NCS3021ZP
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 40 hospitals
  • Product Description
    Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • Manufacturer Address
    Medtronic Vascular, 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • Source
    USFDA