Events

Recall of Device Recall XPOSE 4 Access Device (XP4000) XPOSE 3 Access Device (XP3000) positioners.

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

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
    60987
  • Event Risk Class
    Class 2
  • Event Number
    Z-0968-2012
  • Event Initiated Date
    2011-11-16
  • Event Date Posted
    2012-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106992
  • 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
    Stabilizer,heart - Product Code MWS
  • Reason
    There may be a small perforation in the sterile pouch of select lots of the acrobat v, acrobat suv, and acrobat mechanical stabilizers and the xpose 3 and xpose 4 positioners.
  • Action
    Maquet sent an Urgent Device Removal Immediate Action Required letter dated November 16, 2011 and a Field Action Response forms via Federal Express to to affected customers. The letter identifies the problem, product. risk factors and actions to be taken. Customers were instructed to examine their stocks immediately to determine if they have any of the recalled product. If so, discontinue dispensing (distributing) the lot and complete the Field Action Response form attached to complete and fax the attached Field Action Response form. In addition, it provides instructions for how to return the recalled product to MAQUET. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271. If you have any additional questions, contact your local MAQUET Cardiovascul'ar sales representative or Customer Service at 1-888-880-2874 (6AM -5PM PST).

Device

Device Recall XPOSE 4 Access Device (XP4000) XPOSE 3 Access Device (XP3000) positioners.
  • Model / Serial
    Pre-Market Notification Number: N/A, Class I Exempt Device Device Listing No. 0043888, 0033972  AXIUS XPOSE 3 Off Pump Positioner XP-3000   25037165, 25037244, 25038989, 25040320, 25040776   XPOSE 4 Off Pump Positioner XP-4000   25037059, 25037396, 25037447, 25037894, 25038001, 25038376, 25038550, 25038874, 25039267, 25039158, 25039455, 25039915, 25040060, 25040465, 25040617, 25040866, 25041058, 25041248, 25041714, 25041606, 25042076, 25042550
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Product Description
    XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. || Product Usage: || The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • Manufacturer Address
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA