Recall Z-2472-2008 ยท DQY Catheter, Percutaneous
Medtronic Inc. Cardiac Rhythm Managment
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
| 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
| K021587 | ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A Medtronic Vascular, May 30, 2002 |