Z-2273-2010

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

Name: Z-2273-2010 Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well...
Creator: Medtronic, Inc.
Published: 2010-07-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-07-16 / Terminated / root cause: packaging

FDA source

Medtronic, Inc. began a recall of Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon on 2010-07-16. The reason FDA records is "Product sterility may be compromised due to breach of package seal integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2273-2010
Status: Terminated
Initiated: 2010-07-16
Posted: 2010-08-25
Terminated: 2011-06-07
Recalling firm: Medtronic, Inc.
Product: Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Product sterility may be compromised due to breach of package seal integrity.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Lot numbers: 50517336, 50517337, and 50517339.

Product code MAV

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)