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Gyrus ACMI

Gyrus ACMI, LLC · Model REXDUR-DBA · UDI-DI 00821925008151

FBN Prescription

510(k) clearances

2,300

Adverse events (9 deaths)

Recalls

Facilities

Description

INVISIO FLEXIBLE URETEROSCOPE - DIGITAL Backward Articulating 3.1 mm

Recalls

Date	Firm	Reason
2026-03-23	TANGENT ENDOSCOPY, LLC	Affected devices exhibited fractures at the distal shaft tip without complete detachment.
2024-12-18	Olympus Corporation of the Americas	Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
2023-09-25	Aizu Olympus Co., Ltd.	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo
2022-03-31	Olympus Corporation of the Americas	Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
2020-08-31	Olympus Corporation of the Americas	The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as
2017-12-20	Boston Scientific Corporation	Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
2016-12-12	Olympus Corporation of the Americas	Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perf
2016-04-06	Pentax Medical Company	Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
2016-04-06	Pentax Medical Company	Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

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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.