Events

Rappel de Device Recall TigerPaw System II

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Laax, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70853
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1462-2015
  • Date de mise en oeuvre de l'événement
    2015-03-25
  • Date de publication de l'événement
    2015-04-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135188
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Staple, implantable - Product Code GDW
  • Cause
    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
  • Modèle / numéro de série
    Part number C-TP-1509 (9 connector)  All serial numbers/lots
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Laax, Inc., 151 Lindbergh Ave Ste I, Livermore CA 94551-9497
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA