PZSClass II
Dual Lumen Ecmo Cannula
Cardiovascular · 21 CFR 870.4100
Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
MDR events118All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances4All time
Recent MDR events
118 adverse event reports on file
- MC3Jul 17, 2026InjuryMc3 Inc.3011468686-2026-00052
- MC3Jul 9, 2026MalfunctionMc3 Inc.3011468686-2026-00051
- MC3Jun 21, 2026InjuryMc3 Inc.3011468686-2026-00044
- PROTEK DUO+ CANNULAMay 28, 2026MalfunctionSorin Group Italia9680841-2026-900019
- MC3May 22, 2026DeathMc3 Inc.3011468686-2026-00038
- VENO-VENOUS PROTEK DUO+ CANNULAApr 29, 2026InjurySorin Group Italia1718850-2026-10004
- MC3Apr 15, 2026MalfunctionMc3 Inc.3011468686-2026-00031
- MC3Mar 30, 2026InjuryMc3 Inc.3011468686-2026-00026
- MC3Mar 30, 2026InjuryMc3 Inc.3011468686-2026-00025
- PROTEK D+ ECLS 31FR CANMar 18, 2026MalfunctionSorin Group Italia Srl1718850-2026-90003
Event type breakdown
Injury50
Malfunction50
Death18
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
4 clearances for this product code