Events

Recall of Device Recall Medtronic Attain LDS 6216A, Leftheart delivery system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc. Cardiac Rhythm Managment.

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
    49433
  • Event Risk Class
    Class 2
  • Event Number
    Z-2472-2008
  • Event Initiated Date
    2008-08-27
  • Event Date Posted
    2008-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73317
  • 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
    Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting - Product Code DQY
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Managment, 8200 Coral Sea St Ne, Mounds View MN 55112-4391
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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