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. Th

Recall Insight

This FDA Devices action (record #Z-1121-2014) was formally reported on March 5, 2014, with the manufacturer initiating the action on February 6, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Medtronic Vascular is listed as the recalling firm, operating out of Danvers, MA. Federal records indicate 191 devices units are affected.

The documented reason for this recall is: Incorrect master label. Distribution data in the federal record shows the product reached: Nationwide Distribution including TX, ME, IA, PA, OR, and NH.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.