Events

Recall of Device Recall TigerPaw System II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Laax, 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
    70853
  • Event Risk Class
    Class 1
  • Event Number
    Z-1462-2015
  • Event Initiated Date
    2015-03-25
  • Event Date Posted
    2015-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135188
  • 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
    Staple, implantable - Product Code GDW
  • Reason
    Increase of field reports involving issues with the tigerpaw system ii resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the tigerpaw system ii fastener.
  • Action
    The firm, LAAx, Inc.on behalf of Maquet Medical Systems, sent an "URGENT MEDICAL DEVICE RECALL (Removal) IMMEDIATE ACTION REQUIRED " letter dated March 30, 2015 to all affected sites by express mail. The letter describers the product, problem and actions to be taken. The customers were instructed to examine your inventory immediately to determine if you have any TIGERPAW System II products; remove the products, quarantine them and place in a secure location; complete and return the MEDICAL DEVICE RECALL (Removal) RESPONSE FORM by e-mailing a scanned copy to:Tigerpaw2015@maquet.com or FAX to: 1-(973)-396-3607. If you have acted as a distributor for the TIGERPAW System product II, immediately contact those accounts, advise them of the recall situationa and have them return all stock to you. Your Marquet Medical System USA Sales Representative will contact you to assist with the return of any product. If you have any additional questions, contact your local Maquet Medical Systems USA Sales Representative or our Customer Service at 1-888-880-2874 (6:00 AM - 5:00 PM PST).

Device

Device Recall TigerPaw System II
  • Model / Serial
    Part number C-TP-1509 (9 connector)  All serial numbers/lots
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of:Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sweden, Switzerland, Turkey and United Kingdom.
  • Product Description
    TIGERPAW System II, || Part number C-TP-1509 (9 connector) || The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
  • Manufacturer
    Laax, Inc.

Manufacturer

Laax, Inc.
  • Manufacturer Address
    Laax, Inc., 151 Lindbergh Ave Ste I, Livermore CA 94551-9497
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA