Events

Recall of Device Recall Maquet Getinge Group Pediatric Arterial Cannula

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
    62471
  • Event Risk Class
    Class 2
  • Event Number
    Z-2210-2012
  • Event Initiated Date
    2012-05-29
  • Event Date Posted
    2012-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110719
  • 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
    Cannula, arterial, cardiopulmonary bypass (cpb), embolism protection - Product Code NCP
  • Reason
    Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
  • Action
    Maquet issued Urgent Device 2, Recall letters/Urgent Product Recall Forms dated May 29, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their current stock and identify any affected product and remove from their inventory. Customers were instructed to contact the customer service department at 800-777-4222 (option #2, followed by option #2). Customers were also instructed to completed the enclsoed Recall Form to acknowledge receipt of the notification and to document the current status of the devices shipped to their facility. For questions regarding this recall call 973-709-7660.

Device

Device Recall Maquet Getinge Group Pediatric Arterial Cannula
  • Model / Serial
    510k023251  US Catalog Number 161412 Batch Number 92048923   Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MI, MN and Internationally
  • Product Description
    Maquet Getinge Group Pediatric Arterial Cannula || Maquet Cardiopulmonary AG Kehler Strabe 31 || 76437 Rastatt Germany Phone +49 7222 932-0 || Fax: +49 7222 932-1888 || info.cp@maquet.com || www.maquet.com || Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
  • Manufacturer
    Maquet Inc.

Manufacturer

Maquet Inc.
  • Manufacturer Address
    Maquet Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA