Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Busi
FDA device recall Z-2473-2008 · posted 2008-09-30 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Managment
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 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 Herzegovi
- Date initiated
- 2008-08-27
- Date posted
- 2008-09-30
- Date terminated
- 2011-05-07
- Location
- Mounds View, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 (K021589) | Medtronic Vascular | 2002-05-30 |