Medtronic Vascular: Medical Device Recall in 2014 - (Recall #: Z-1121-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: February 6, 2014

Date Posted: March 5, 2014

Recall Number: Z-1121-2014

Event ID: 67490

Reason for Recall:

Incorrect master label.

Status: Terminated

Product Quantity: 191 devices

Code Information:

Lot Number: 50755851

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated