Recall Z-2738-2026— Medtronic Perfusion Systems
Class II · Ongoing
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2026-05-25. It names 2 FDA 510(k) clearances: K180456, K024069. Product: Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; 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
2 on FDA's record- K180456 — Bio-Medicus Adult Cannulae Kit
- K024069 — ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
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 One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; 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.