Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monito
FDA device recall Z-2272-2010 · posted 2010-08-25 · Terminated
Recall details
- Recalling firm
- Medtronic, Inc.
- Reason for recall
- Product sterility may be compromised due to breach of package seal integrity.
- Action taken
- Medtronic issued a Urgent Medical Device Recall Notice to US customer on 7/15/2010 and to foreign accounts advising of the issue and requesting that they segregate recalled product. A Medtronic Sales Rep will visit their facility to account for all affected product and initiate a credit. Foreign accounts will return product to their respective distribution centers.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MAV
- Quantity affected
- 768 units
- Distribution
- Worldwide Distribution -- USA, including the state of MI and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, P
- Date initiated
- 2010-07-16
- Date posted
- 2010-08-25
- Date terminated
- 2011-06-07
- Location
- Danvers, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT (K960983) | Medtronics Interventional Vascular | 1996-05-30 |
| MEDTRONIC EVEREST INFLATION DEVICE (K942269) | Medtronics Interventional Vascular | 1994-10-18 |