FDA recall Z-0623-2024

Medtronic Inc. · Class II · device

Product

Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.

Reason for recall

Seal defects could compromise the ability of the product packaging to maintain sterility.

Distribution

US Nationwide distribution in the state of MN.

Key facts

Status
Completed
Initiation date
2023-11-20
Report date
2024-01-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0623-2024