QHWClass II
Single Lumen Ecmo Cannula
Cardiovascular · 21 CFR 870.4100
Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure 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 events38All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances3All time
Recent MDR events
38 adverse event reports on file
- BIO-MEDICUS LIFE SUPPORT TMJul 22, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-04543
- BIO-MEDICUS LIFE SUPPORT TMJun 10, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-03688
- BIO-MEDICUS LIFE SUPPORT TMMar 25, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-02020
- BIO-MEDICUS LIFE SUPPORT TMJan 7, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-00100
- BIO-MEDICUS LIFE SUPPORT TMAug 1, 2025InjuryMedtronic Mexico S. De R.l. De Cv9612164-2025-03762
- BIO-MEDICUS LIFE SUPPORT TMJul 31, 2025MalfunctionMedtronic Mexico S. De R.l. De Cv9612164-2025-03732
- BIO-MEDICUS LIFE SUPPORT TMJul 29, 2025MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2025-00720
- BIO-MEDICUS LIFE SUPPORT TMJul 21, 2025MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2025-00662
- BIO-MEDICUS LIFE SUPPORT TMJul 4, 2025MalfunctionMedtronic Mexico S. De R.l. De Cv9612164-2025-03291
- BIO-MEDICUS LIFE SUPPORT TMJan 30, 2025MalfunctionMedtronic Mexico S. De R.l. De Cv9612164-2025-00502
Event type breakdown
Malfunction35
Injury3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
510(k) clearances
3 clearances for this product code