Recall Z-2273-2010 ยท MAV Syringe, Balloon Inflation
Medtronic, Inc.
Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
| Date | Aug 25, 2010 (initiated Jul 16, 2010) |
| Status | Terminated |
| Reason | Product sterility may be compromised due to breach of package seal integrity. |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 1,254 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, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom. |
| FDA record | Open on fda.gov |