Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
This recall has been terminated (originally issued August 25, 2010).
- Company
- Medtronic, Inc.
- Recall Initiated
- July 16, 2010
- Posted
- August 25, 2010
- Terminated
- June 7, 2011
- Recall Number
- Z-2271-2010
- Quantity
- 2,875 units
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Product sterility may be compromised due to breach of package seal integrity.
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.
Lot / Code Info
Lot numbers: 50517330, 50517331,50517332, 50517333, 50517334, 50519716, 50519717, 50519718, and 50519679.
Root Cause
Packaging process control
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.