Recall Z-2219-2026— Medtronic Perfusion Systems
Class II · Ongoing
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2026-04-21. It names 2 FDA 510(k) clearances: K953945, K860149. Product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; 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
2 on FDA's record- K953945 — RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
- K860149 — VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015
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 DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; 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.