Events

Recall of Device Recall Maquet Inc.

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

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
    74225
  • Event Risk Class
    Class 2
  • Event Number
    Z-1935-2016
  • Event Initiated Date
    2016-05-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146871
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • Reason
    It was discovered during post-quarantine packaging on 2/16/2016 that the ifu for the statlock sheath stabilization device for percutaneous sheath introducer (vendor pn 2403097-1405r) was erroneously packaged with the mega and sensation plus iab catheter kits instead of the ifu for the statlock catheter stabilization device for iab catheters (vendor pn 24030905-1406r).
  • Action
    Maquet Inc sent an Urgent Medical Device Field Correction Letter/Response Form dated 5/13/2016 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Device

Device Recall Maquet Inc.
  • Model / Serial
    (PN 0684-00-0294-01U) (PN 0684-00-0294-02U) (PN 0684-00-0295-01U) (PN 0684-00-0295-02U) (PN 0684-00-0296-01U)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ || MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ || MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ || MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Manufacturer Address
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA