Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Attain LDS 6216A, Leftheart delivery system

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Medtronic Attain LDS 6216A, Leftheart delivery system see related information
Date Initiated by Firm August 27, 2008
Date Posted September 30, 2008
Recall Status1 Terminated 3 on May 07, 2011
Recall Number Z-2472-2008
Recall Event ID 49433
510(K)Number K021587  
Product Classification Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting - Product Code DQY
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Managment
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact
763-526-0000
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 35,193 total
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = MEDTRONIC VASCULAR
-
-