FDA Device recall Z-1121-2014
Medtronic Everest 20cc Inflation Device
- FDA Device
- Class III
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class III recall of Medtronic Everest 20cc Inflation Device by Medtronic Vascular, citing incorrect master label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1121-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-02-06 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Vascular |
| Distribution | US |
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.
Reason
Incorrect master label.
Identifiers
| code_info | Lot Number: 50755851 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1121-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.