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THD SLIDE ONE

THD SPA · Model THD DOPPLER PROBE (1s/ST) · UDI-DI 18033737710354

JAF Prescription

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

THD Doppler Prbe is intended to be used with THD Revolution device for the treatment of haemorrhoidal disease, using the Transanal Haemorrhoidal Dearterialization technique. THD Doppler Probe in intended to be coupled with the THD Slide proctoscope and has been designed to obtain the maximum sensitivity to identify blood vessels. Its small size allows the physician an easy handling when used with the THD Slide proctoscope, which has a port to lodge the THD Doppler Probe body, leaving the operating field unobstructed. THD Doppler Probe (1s/ST) is individually packed and EO sterilized.

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.