Z-1121-2014Class III

Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation...

Name: Z-1121-2014 Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation...
Creator: Medtronic Vascular
Published: 2014-02-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-02-06 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Vascular began a recall of Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate... on 2014-02-06. FDA classified it as Class III and gives the reason as "Incorrect master label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1121-2014
Classification: Class III
Status: Terminated
Initiated: 2014-02-06
Posted: 2014-02-26
Terminated: 2014-06-02
Recalling firm: Medtronic, Inc.
Product: Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Incorrect master label.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Medtronic sent an Urgent Medical Device Recall letter on February 6, 2014, via UPS 3-day delivery. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product that remains in their inventory. Return the affected product to Medtronic: Contact Customer Service at 888-283-7868 and reference RADAR # 170276 to initiate a return and credit of product. Complete the attached Customers Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. If any affected product has been forwarded to another facility, customers were asked to notify that facility accordingly and facilitate the retrieval of the affected product. Customers with questions were instructed to contact their Medtronic representative. For questions regarding this recall call 888-283-7868.
Quantity in commerce: 191 devices
Distribution: Nationwide Distribution including TX, ME, IA, PA, OR, and NH.
Product codes and lots: Lot Number: 50755851

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1121-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1121-2014	Class III	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26

Product code MAV

K942269Class IIMedtronic Everest Inflation DeviceMedtronics Interventional Vascular / cleared 1994-10-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)