Device 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.
Z-1121-2014
Product summary
- Event
- Event 67490
- Status
- Terminated
- Classification
- Class III
- Quantity
- 191 devices
- Official record key
device-enforcement:Z-1121-2014
Official wording
Reason: Incorrect master label.
Code information: Lot Number: 50755851
Distribution pattern: Nationwide Distribution including TX, ME, IA, PA, OR, and NH.
Derived failure modes
-
Unknown
Incorrect master label.