Medtronic Everest 20cc Inflation Device Recalled for Incorrect Master Label
Medtronic Vascular is recalling 191 Everest 20cc Inflation Devices due to an incorrect master label. The devices are sterile, single-use tools used to inflate balloon catheters.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific defect is a labeling error.
Plain-English summary
Medtronic Vascular is recalling 191 units of the Everest 20cc Inflation Device, Model Number AC2205P, due to an incorrect master label. The device is designed to inflate and deflate balloon catheters and monitor pressure within the balloon. It is a sterile, single-use device that does not come in direct contact with the patient and is not implanted.
The recall covers devices with Lot Number 50755851. The distribution was nationwide, including Texas, Maine, Iowa, Pennsylvania, Oregon, and New Hampshire. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare providers and facilities that have received these devices should stop using them and contact Medtronic Vascular for instructions on return or disposal. Consumers are unlikely to have access to this professional medical device, but if they possess one, they should not use it and should contact the manufacturer.
The recalled product
- 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…
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 191
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 50755851
Distribution
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