Recall Z-2215-2026— Medtronic Perfusion Systems

Name: FDA recall Z-2215-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-21

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2026-04-21. It names one FDA 510(k) clearance: K860149. Product: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter. Reason: Certain lots of product have the potential for a sterile barrier breach..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2026-04-21
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K860149 — VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015Dlp, Inc.·cleared 1986-03-31

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 GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter

Reason for recall

Certain lots of product have the potential for a sterile barrier breach.

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