Events

Recall of Device Recall Possis AngioJet Rheolytic Thrombectomy SystemSpiroflex Catheter

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

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
    37919
  • Event Risk Class
    Class 3
  • Event Number
    Z-0954-2007
  • Event Initiated Date
    2007-05-01
  • Event Date Posted
    2007-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52238
  • 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
    Coronary Catheter - Product Code MCX
  • Reason
    Mislabeling: xmi (otw) catheters were mislabeled as xmi-rx units and avx catheters were mislabeled as spiroflex catheters.
  • Action
    Consignees were notified of the problem on May 1, 2007 via a Urgent Medical Device Recall Letter. The consignees were instructed to quarantine the product until a Possis Representative contacts them. The representative will examine the units and determine which ones to be returned to Possis. They were also asked to fill and return the attached form.

Device

Device Recall Possis AngioJet Rheolytic Thrombectomy SystemSpiroflex Catheter
  • Model / Serial
    Model #: 105835-001 Lot # 73082
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide including states of AK, AR, AZ, CA, CT, FL,IL, IN, KY, MD, ME, MI, MN, MS, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, WA, and WI.
  • Product Description
    Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA- || (Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).
  • Manufacturer
    Possis Medical, Inc

Manufacturer

Possis Medical, Inc
  • Manufacturer Address
    Possis Medical, Inc, 9055 Evergreen Blvd Nw, Minneapolis MN 55433-5833
  • Source
    USFDA