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Endophys Pressure Sensing Sheath Kit - 8F 25 CM

ENDOPHYS HOLDINGS, LLC · Model PSS-10-0825200-SCN · UDI-DI 00852004007079

DXO DYB Prescription

510(k) clearances

2,406

Adverse events (21 deaths)

Recalls

Facilities

Description

The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer, and a vessel dilator . Used in conjunction with the Endophys Blood Pressure Monitor it is used to continuously monitor patient blood pressure during procedures requiring vascular access.

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 (clearance) of the devic
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 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.