Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Cardiovascular · 21 CFR 870.4100
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Recent MDR events
505 adverse event reports on file
- VitalFlow SetJul 27, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-04584
- XLUNG Kit 230Jul 27, 2026MalfunctionXenios Ag3012172416-2026-00060
- Novalung console (Linux Board)Jul 27, 2026MalfunctionXenios Ag3012172416-2026-00061
- Novalung console (Linux Board)Jul 27, 2026MalfunctionXenios Ag3012172416-2026-00062
- XLUNG Kit 230Jul 27, 2026MalfunctionXenios Ag3012172416-2026-00063
- VITALFLOW SETJul 21, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-04503
- XLUNG Kit 230Jul 12, 2026MalfunctionXenios Ag3012172416-2026-00059
- NOVALUNG CONSOLE (LINUX BOARD)Jul 10, 2026MalfunctionXenios Ag3012172416-2026-00058
- XLUNG Kit 230Jun 26, 2026MalfunctionXenios Ag3012172416-2026-00057
- Novalung console (Linux Board)Jun 25, 2026MalfunctionXenios Ag3012172416-2026-00054
Event type breakdown
Recalls
2 recall events for this product code
- Fresenius Medical Care Holdings, Inc.Open, ClassifiedMay 15, 2024
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides as
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
Z-1822-2024 · View FDA record ↗ - Fresenius Medical Care Holdings, Inc.Open, ClassifiedUnknown
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)-
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.
Z-0562-2022 · View FDA record ↗
Registered firms
12 firms currently registered for this product code
Tst Gmbh
Gernsheim Hesse, DE
Xenios Ag
Stolberg North Rhine-Westphalia, DE
Xenios Ag
Heilbronn Baden-Wurttemberg, DE
Xenios Ag
Reutlingen Baden-Wurttemberg, DE
Mc3, Inc.
Dexter, MI, US
Sterigenics Eo Canada, Inc.
Mississauga Ontario, CA
Pabst Transport Gmbh & Co. Kg
Gochsheim Bavaria, DE
Medtronic Mexico S. De R.l. De Cv
Tijuana Baja California, MX
510(k) clearances
4 clearances for this product code
- Medtronic, Inc.Jul 31, 2026
K261335 · VitalFlow Set with Balance Biosurface
- Medtronic, Inc.Sep 12, 2024
K240880 · VitalFlow Set with Balance Biosurface
- Fresenius Medical Care Renal Therapies Group, LLCApr 15, 2024
K232926 · Novalung ultimate kit (US)
- Fresenius Medical Care Renal Therapies Group, LLCFeb 21, 2020
K191407 · Novalung System