FDA Medical Device Recalls (openFDA)
Medtronic, Inc.: Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
- Recall number
- Z-2273-2010
- Recalling firm
- Medtronic, Inc.
- Product
- Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
- Status
- Terminated
- Initiated
- 2010-07-16
- Posted
- 2010-08-25
- Terminated
- 2011-06-07
- Reason
- Product sterility may be compromised due to breach of package seal integrity.
- Root cause
- Packaging process control
- Action
- 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.
- Quantity
- 1,254 units
- 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.
- Lot, serial or model codes
- Lot numbers: 50517336, 50517337, and 50517339.
- 510(k) numbers
- ["K942269","K960983"]
- PMA numbers
- not on file
- Product code
- MAV
- Firm FEI
- 1220452
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28