Recall Z-1803-2024— Medtronic Perfusion Systems

Name: FDA recall Z-1803-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-19

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2024-03-19. It names one FDA 510(k) clearance: K120612. 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: Potential for unsealed sterile packing..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2024-03-19
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K120612 — MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNTMedtronic, Inc.·cleared 2012-05-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.