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THD REVOLUTION

THD SPA · Model THD REVOLUTION (US) · UDI-DI 18033737710842

JAF Prescription

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

THD Revolution is an electromedical device which, combined with the THD Kits, makes it possible to perform ligation of the haemorrhoidal arteries using a Doppler probe and subsequent mucopexy to correct prolapse. THD Revolution is equipped with a Doppler module with high sensitivity digital signal processing, with automatic reduction of background noise. The device is equipped with a display for monitoring operations, to guide the operator through the various settings, to provide information on the status of the device and any accessories connected to it. Device functions are easily operated through the buttons on the front.

Recalls

Date	Firm	Reason
2023-02-10	Unetixs Vascular, Inc.	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10	Unetixs Vascular, Inc.	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10	Unetixs Vascular, Inc.	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10	Unetixs Vascular, Inc.	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2017-06-09	Natus Neurology Inc	Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood
2017-06-09	Natus Neurology Inc	Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood
2017-06-09	Natus Neurology Inc	Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood
2017-06-09	Natus Neurology Inc	Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood

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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.