Events

Rappel de Device Recall Medtronic Attain LDS 6216A, Leftheart delivery system

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 Medtronic Inc. Cardiac Rhythm Managment.

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
    49433
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2472-2008
  • Date de mise en oeuvre de l'événement
    2008-08-27
  • Date de publication de l'événement
    2008-09-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73317
  • 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
    Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting - Product Code DQY
  • Cause
    Medtronic has identified an issue with the packaging for specific lots of the medtronic adjustable valve and valves contained in the attain left heart delivery system kits. a small number of valve package seals could be compromised.
  • Action
    An Urgent Device Recall letter, dated August 28, 2008, was sent to affected consignees. The letter describes the issue, identifies affected product, and requests that affected product be removed from inventory and returned to Medtronic. Medtronic representatives with assist in returning unused valves and kits and provide replacements. Contact Medtronic at 1-763-526-0000 for assistance.

Device

Device Recall Medtronic Attain LDS 6216A, Leftheart delivery system
  • Modèle / numéro de série
    Lot numbers: 0000561685, 0000561687, 0000564043, 0000572082, 0000572084,0000572086, 0000572326, 0000578715, 0000584146, 0000584147, 0000584220, 0000594827, 0000594840, 0000594855, 0000611672, 0000611681, 0000618331, 0000618337, 0000623483, 0000623487, 0000626572, 0000626573, 0000636688, 0000639819, 0000639820, 0000642702, 0000648673, 0000648675, 0000658459, 0000658917, 0000662611, 0000662613, 0000666446, 0000675923, 000678213, 0000679453, 0000679473, 0000679474, 0000688351, 0000688352, 0000690991, 0000699022, 0000700460, 0000700467, 0000700647, 0000700648, 0000700649, 0000700650, 0000715602, 0000723321, 0000733095, 0000738118, 0000741796, 0000741799, 0000741806, 0000741817, 0000741820, 0000753218, 0000758162, 0000760125, 0000763744, 0000763746
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and except states OR, RI, and SD. Puerto Rico and Washington D.C. , and countries of Algeria , Argentina , Australia , Austria , Belgium , Bosnia And Herzegovina , Canada , Chile , Croatia , Czech Republic , Denmark , Egypt , Finland , France , Georgia , Germany , Greece , Guadeloupe , Hong Kong , Hungary , India , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Kuwait , Lithuania , Malta , Martinique , Morocco , Netherlands , Norway , Pakistan , Poland , Portugal , Puerto Rico ,Qatar , Reunion , Romania , Saudi Arabia , Slovakia , Slovenia , South Africa , Spain , Sri Lanka , Sweden , Switzerland , Syrian Arab Republic , Tunisia , Turkey , UK , Ukraine , United Arab Emirates , Uruguay , and Venezuela.
  • Description du dispositif
    Medtronic Attain LDS 6216A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432 USA. The Medtronic Attain LDS Model 6216A Left-heart delivery system is designed to facilitate lead implantation in the left heart, via the coronary sinus. The Left-heart delivery system features one guide wire to facilitate venous access, an adjustable valve to reduce blood loss during the implant procedure, two pre-shaped guide catheters for passing venogram balloon catheters and appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Managment, 8200 Coral Sea St Ne, Mounds View MN 55112-4391
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA