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.
This recall has been terminated (originally issued September 30, 2008).
- Recall Initiated
- August 27, 2008
- Posted
- September 30, 2008
- Terminated
- May 7, 2011
- Recall Number
- Z-2471-2008
- Quantity
- 35,193 total
- Firm Location
- Mounds View, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Lot numbers: 33901607, 33907906, 33909207, 33913206, 33914207, 33917207, 33921308, 33925707, 33929306, 33931107, 33933205, 33934905, 33936105
Root Cause
Process control
Action Taken
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.