Devices

Olympus Recalls ViziShot 2 FLEX Needles

Olympus has recalled (Class 1) its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured prior to 5/12 after receiving reports of device components detaching during procedures.

The ViziShot 2 FLEX is protected by a hypotube and sheath, a recall notice says, adding that the “hypotube protects the sheath from the needle tip and provides stability during transit and insertion. If damage to the sheath has occurred and the device continues to be used, the hypotube has the potential to eject from the device along with detached plastic components, which are not radiopaque. Damage may also occur during the manufacturing process.”

To improve device damage detection at the point of manufacturing, Olympus says it has implemented an automated inspection procedure during assembly, a process step that had been conducted previously through visual inspection.

The device is designed to be used with ultrasound endoscopes for ultrasound-guided fine needle aspiration and fine needle biopsy of submucosal and extramural lesions of the tracheobronchial tree.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome