FDA Medical Device Recalls (openFDA)
Medtronic Emergency Response Systems, Inc.: Hard shell carry case for the LIFEPAK 500 AED.
- Recall number
- Z-0004-06
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Product
- Hard shell carry case for the LIFEPAK 500 AED.
- Status
- Terminated
- Initiated
- 2005-07-12
- Posted
- 2005-10-04
- Terminated
- 2006-06-26
- Reason
- Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
- Root cause
- Process control
- Action
- On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.
- Quantity
- 4608 cases
- Distribution
- Cases were distributed nationwide and internationally.
- Lot, serial or model codes
- Cases do not contain serial numbers or lot numbers. Catalog number 3005384-000 through 002
- 510(k) numbers
- ["K010918"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3015876
- Firm city
- Redmond
- Firm state
- WA
- 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