Home › Device types › DXO
Transducer, Pressure, Catheter Tip
FDA product code DXO · Class 2 · Cardiovascular
778
Registered devices
2,389
Adverse events
10
Recalls
64
510(k) clearances
Devices with this code
OptoMonitor 3 — Opsens IncTRUWAVE,VAMP PLUS — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCTRUWAVE, VAMP JR. — Edwards Lifesciences LLCOptoMonitor 3 — Opsens IncTRUWAVE — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCTRUWAVE, VAMP PLUS — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCTRUWAVE X 2 (3CC) / VAMP JR 54 IN (136 CM) — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCPX1800 – Truwave Cables — Edwards Lifesciences LLCTRUWAVE, VAMP PLUS — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCTRUWAVE X 3 (3 CC) /VAMP 75 IN (190 CM) — Edwards Lifesciences LLCTRUWAVE — Edwards Lifesciences LLCOptoMonitor 3 — Opsens IncOptoMonitor 3 — Opsens IncOptoMonitor 3 — Opsens Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-26 | Edwards Lifesciences, LLC | There is a potential that the pressure tubing may detach from the blood sampling system |
| 2021-05-26 | Edwards Lifesciences, LLC | There is a potential that the pressure tubing may detach from the blood sampling system |
| 2021-05-26 | Edwards Lifesciences, LLC | There is a potential that the pressure tubing may detach from the blood sampling system |
| 2021-05-26 | Edwards Lifesciences, LLC | There is a potential that the pressure tubing may detach from the blood sampling system |
| 2021-05-26 | Edwards Lifesciences, LLC | There is a potential that the pressure tubing may detach from the blood sampling system |
| 2021-05-26 | Edwards Lifesciences, LLC | There is a potential that the pressure tubing may detach from the blood sampling system |
| 2021-05-26 | Edwards Lifesciences, LLC | There is a potential that the pressure tubing may detach from the blood sampling system |
| 2021-05-26 | Edwards Lifesciences, LLC | There is a potential that the pressure tubing may detach from the blood sampling system |
| 2015-11-13 | Edwards Lifesciences, LLC | Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (cle |
| 2015-07-31 | Edward Lifesciences, Llc | Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inabil |
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