Olympus Corp. is recalling its ViziShot 2 FLEX needles manufactured prior to May 12 after reports of the device components detaching during procedures.
The company assessed the needles after it received complaints of a patient injury and one death, according to a Sept. 19 company news release. In response to the reports, Olympus has implemented an automated inspection procedure during assembly — which was previously done through visual inspection — to improve detection of damaged devices.
The device is designed to be used with ultrasound endoscopes for lung cancer biopsies.
