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Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)

Micro-Tech (Nanjing) Co., Ltd. · Model EUS-19-0-N · UDI-DI 06932503534581

ODG Prescription

510(k) clearances

17,738

Adverse events (32 deaths)

Recalls

Facilities

Description

Sheath: 1.8mm, Needle: 1.1mm, Needle Length out of sheath: 80mm, Material: Co-Cr Alloy, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle

Recalls

Date	Firm	Reason
2026-09-09	Pentax of America Inc	Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
2026-09-09	Pentax of America Inc	Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
2026-09-09	Pentax of America Inc	Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
2026-09-09	Pentax of America Inc	Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
2020-10-16	Olympus Corporation of the Americas	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2020-10-16	Olympus Corporation of the Americas	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2020-10-16	Olympus Corporation of the Americas	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2020-10-16	Olympus Corporation of the Americas	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2018-03-12	Micro-Tech (Nanjing) Co., Ltd.	The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of
2018-03-12	Micro-Tech (Nanjing) Co., Ltd.	The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of

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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.