FDA recall Z-1803-2024

Medtronic Perfusion Systems · Class II · device

Product

Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200

Reason for recall

Potential for unsealed sterile packing.

Distribution

Worldwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-03-19
Report date: 2024-05-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1803-2024