Medtronic Everest 20 Disposable Inflation Device, AC2200 recallZ-2271-2010 · Medtronic, Inc. · initiated Jul 16, 2010
Terminated All recalls posted in August 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product sterility may be compromised due to breach of package seal integrity.
FDA root cause category: Packaging process control
What the company is doing
Medtronic issued a Urgent Medical Device Recall Notice to US customer on 7/15/2010 and to foreign accounts advising of the issue and requesting that they segregate recalled product. A Medtronic Sales Rep will visit their facility to account for all affected product and initiate a credit. Foreign accounts will return product to their respective distribution centers.
Recall details
- Recall number
- Z-2271-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 16, 2010
- Posted by the FDA
- Aug 25, 2010
- Recalling firm
- Medtronic, Inc.
- Quantity
- 2,875 units
- Product code
- MAV
- FDA submissions
- K942269, K960983
- Distribution
- Worldwide Distribution -- USA, including the state of MI and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom.
Product description
Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
Code information (models, lots, serial numbers)
Lot numbers: 50517330, 50517331,50517332, 50517333, 50517334, 50519716, 50519717, 50519718, and 50519679.
Other devices under the same FDA submission
1 device cleared under K942269, K960983 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EVEREST™ AC3200Medtronic, Inc. · Syringe, balloon inflation1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 56276).
- Z-2272-2010 · TerminatedMedtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
- Z-2273-2010 · TerminatedMedtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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