—#93121

Product

Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

FDA product code: MAV — Syringe, Balloon Inflation
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K942269, K960983
Affected lot / code info: Lot numbers: 50517336, 50517337, and 50517339.

Why it was recalled

Product sterility may be compromised due to breach of package seal integrity.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Medtronic, Inc.
Address: 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-07-16
Posted by FDA: 2010-08-25
Terminated: 2011-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93121. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.