Medtronic Emergency Response Systems, Inc. Hard shell carry case for the LIFEPAK 500 AED. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hard shell carry case for the LIFEPAK 500 AED.
Brand
Medtronic Emergency Response Systems, Inc.
Lot Codes / Batch Numbers
Cases do not contain serial numbers or lot numbers. Catalog number 3005384-000 through 002
Products Sold
Cases do not contain serial numbers or lot numbers. Catalog number 3005384-000 through 002
Medtronic Emergency Response Systems, Inc. is recalling Hard shell carry case for the LIFEPAK 500 AED. due to Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it dif. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026