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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Adjustable valve

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  Class 2 Device Recall Medtronic Adjustable valve 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-2471-2008
Recall Event ID 49433
510(K)Number K052459  
Product Classification Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting - Product Code DTL
Product Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL adjustable valve is an accessory designed for use with Medtronic delivery systems to reduce blood loss during percutaneous catheter procedures. It consists of an adjustable valve and flush port.
Code Information Lot numbers: 33901607, 33907906, 33909207, 33913206, 33914207, 33917207, 33921308, 33925707, 33929306, 33931107, 33933205, 33934905, 33936105
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 = DTL and Original Applicant = MEDTRONIC VASCULAR
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