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Terminated

Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

FDA Recall Z-2272-2010 · Posted 2010-08-25

Recalling FirmMedtronic, Inc.
Recall StatusTerminated
Product CodeMAV
Date Initiated2010-07-16
Date Terminated2011-06-07
Product Quantity768 units

Reason for Recall

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

Firm 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.

Root Cause

Packaging process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960983MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KITMedtronics Interventional Vascular · 1996-05-30K942269MEDTRONIC EVEREST INFLATION DEVICEMedtronics Interventional Vascular · 1994-10-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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