Medtronic Vascular recalls Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device i

Recalled March 5, 2014 · FDA recall Z-1121-2014 · Medtronic Vascular

Hazard

Incorrect master label. · FDA Class III

Units

191 devices

Sold at

Nationwide Distribution including TX, ME, IA, PA, OR, and NH.

Description

Incorrect master label.

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.

Manufacturer(s)

Medtronic Vascular

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →