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OptoMonitor 3

Opsens Inc · Model AO cable - Schwarzer Cardis 5000 · UDI-DI 07540184013166

DXO Prescription
4
510(k) clearances
2,389
Adverse events (20 deaths)
10
Recalls
64
Facilities

Recalls

DateFirmReason
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26Edwards Lifesciences, LLCThere is a potential that the pressure tubing may detach from the blood sampling system
2015-11-13Edwards Lifesciences, LLCEdward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devic
2015-07-31Edward Lifesciences, LlcFlow 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 inability to prime the sys

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.