Medtronic Everest 20cc Inflation Device recall
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.
Why was Medtronic Everest 20cc Inflation Device recalled?
Incorrect master label.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 50755851
- 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.
- Recalling firm
- Medtronic Vascular
- Quantity
- 191 devices
- Distribution
- Nationwide Distribution including TX, ME, IA, PA, OR, and NH.
- Recall date
- March 5, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)