Events

Recall of Device Recall Valve XS Atrium Retractable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap, 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
    72712
  • Event Risk Class
    Class 2
  • Event Number
    Z-0566-2016
  • Event Initiated Date
    2015-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142017
  • 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
    Retractor - Product Code GAD
  • Reason
    Aag received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an fc424r blade. investigation revealed that the corrosion was due to incorrect material used in the manufacturing of the disk spring of the ball joint by the supplier.
  • Action
    The firm, Aesculap, sent an "URGENT MEDICAL DEVICE CORRECTION OR REMOVAL" letter dated 11/17/2015 to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to review the product recall notification in its entirety; do not destroy any affected product; if you have no inventory remaining, notate that on the Product Removal Acknowledgement Form; contact our customer service department for an RGR at 866-229-3002 or email: SetWorld_Orders.BBMUS_Service@aesculap.com and immediately return affected product; complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance department by fax to 610-791-6882 or email to val.strawn@Aesculap.com within two(2) weeks of receipt, even if the total inventory in your possession is zero (0) Sales Representative will make an appointment to come and exchange the effected product with an interium solution (FC360-Atrium Lift Retractor Set) that will allow any scheduled or unexpected cases, which would require the use of this product. The newly manufactured product will ship automatically when it's available.Then a visit will be scheduled to retrieve the loaner FC360R sets. If you have any questions, contact Quality Specialist at 610-984-9414 or email to val.strawn@aesculap.com or Product Manager at 610-984-9150 or email to mark.eppedio@aesculap.com.

Device

Device Recall Valve XS Atrium Retractable
  • Model / Serial
    Product Information All lots affected  Product Description FC424R Valve XS Atrium Lift Ret. Blade50X35 FC425R Valve XS Atrium Lift Ret. Blade60X35 FC426R Valve XS Atrium Lift Ret. Blade70X35 FC428R Valve XS Atrium Lift Ret. Blade50X45 FC429R Valve XS Atrium Lift Ret. Blade60X45 FC430R Valve XS Atrium Lift Ret. Blade70X45 FC431R Valve XS Atrium Lift Ret. Blade25X20 FC432R Valve XS Atrium Lift Ret. Blade25X25 FC433R Valve XS Atrium Lift Ret. Blade40X25 FC434R Valve XS Atrium Lift Ret. Blade50X25 FC435R Valve XS Atrium Lift Ret. Blade25X40 FC436R Valve XS Atrium Lift Ret. Blade25X50 FC420R Valve XS Atrium Lift Ret. Blade Complete Set
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to state of: NY.
  • Product Description
    Valve XS Atrium Retractor || FC429R || 52154756 || The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
  • Manufacturer
    Aesculap, Inc.

Manufacturer

Aesculap, Inc.
  • Manufacturer Address
    Aesculap, Inc., 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA