Recall Z-0984-2025— Medtronic Perfusion Systems

Name: FDA recall Z-0984-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-12

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2024-12-12. It names one FDA 510(k) clearance: K024069. Product: DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr). Reason: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2024-12-12
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K024069 — ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106Medtronic Vascular·cleared 2003-01-08

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

DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

Reason for recall

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

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