Events

Recall of Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet 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
    32267
  • Event Risk Class
    Class 2
  • Event Number
    Z-1061-05
  • Event Initiated Date
    2005-05-20
  • Event Date Posted
    2005-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39478
  • 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
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Reason
    Upon acquisition of jostra ag, manufacturer of polystan coronary cannula balloon tip catheters, maquet was unable to confirm the catheter's fda approval status.
  • Action
    Maquet Cardiopulmonary AG, Germany through their US firm Maquet, Inc. notified Surgemedical, Inc to return all cannula identified with the Ref. Number 22xxxx back to Maquet Cardiopulmonary.

Device

Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
  • Model / Serial
    Lot numbers: 162119; 162572; 163299; 164050; 165934; 167444; 167446; 171658; 176841; 178282; 179626; 180352; 180822; 184419; 185618; 186149; 187100; 188865.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Maquet Cardiopulmonary AG, Hirrlingen, Germany has one US distributor, Surgemedical Inc., Holland, Michigan. The firm is to return all cannula in their possession back to Maquet.
  • Product Description
    Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
  • Manufacturer
    Maquet Inc

Manufacturer

Maquet Inc
  • Manufacturer Address
    Maquet Inc, 1140 Route 22 East, Bridgewater NJ 08807-2912
  • Source
    USFDA