Recall Z-1121-2014— Medtronic Vascular

Name: FDA recall Z-1121-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-06

Class III · Terminated

Class III FDA medical device recall by Medtronic Vascular, initiated 2014-02-06, terminated 2014-06-02. It names one FDA 510(k) clearance: K942269. 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.. Reason: Incorrect master label..

Recalling firm: Medtronic Vascular
Classification: Class III
Status: Terminated
Initiated: 2014-02-06
Terminated: 2014-06-02
Firm location: Danvers, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K942269 — MEDTRONIC EVEREST INFLATION DEVICEMedtronics Interventional Vascular·cleared 1994-10-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Incorrect master label.

Data sourced from openFDA. This site is unofficial and independent of the FDA.