Recall Z-2471-2008 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Medtronic Inc. Cardiac Rhythm Managment
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.
| Date | Sep 30, 2008 (initiated Aug 27, 2008) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 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 , Ger |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052459 | 6248VAL ADJUSTABLE VALVE Medtronic Vascular, Jan 11, 2006 |