FDA recall Z-0289-2025

Medtronic Perfusion Systems · Class II · device

Product

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

Reason for recall

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

Distribution

US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore

Key facts

Status
Ongoing
Initiation date
2024-10-03
Report date
2024-11-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0289-2025