Recall Z-2739-2026— Medtronic Perfusion Systems

Name: FDA recall Z-2739-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-25

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2026-05-25. It names one FDA 510(k) clearance: K153598. Product: Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula. Reason: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2026-05-25
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K153598 — Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc.·cleared 2016-01-15

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 Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula

Reason for recall

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

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