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Recall Observatory FDA recall evidence

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

February 06, 2014

Class III

Product summary

Firm
Medtronic Vascular
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

    reason.no_named_rule · v1.0.0

    Incorrect master label.