FDA announces recall of biopsy device after 14 injuries and 1 death
The U.S. Food and Drug Administration on Wednesday announced the recall of an image-guided device from Olympus following 14 injuries and one death.
Its alert pertains to the ViziShot 2 FLEX (19G), designed for ultrasound fine needle aspiration and fine needle biopsy. Olympus notes the product is used for diagnosing lung disease and staging lung cancer, enabling physicians to obtain samples “in the most challenging locations.”
There have been reported safety issues with the ViziShot 2 caused by a potentially deformed a-traumatic tip, the FDA noted. Devices manufactured before May 12 with this defect could cause hypotube component ejection or detached plastic components. Both, the agency said, have the potential to enter the airways of the lungs, requiring intervention for removal.
“The use of affected product may cause serious adverse health consequences, including mucosal injury and bleeding from loose components entering the tracheobronchial tree or additional procedures for removal, infection and death,” the FDA notice said, labeling this as a Class 1 recall, its most serious designation.
Olympus has begun removing certain ViziShot needles from the market in response to the issue, with over 103,000 units impacted. It sent customers an Urgent Medical Device Removal letter on Aug. 6, offering guidance. Olympus is urging physicians not to use any ViziShot 2 Flex (19G) devices from certain lot numbers. The company also is reinforcing existing warnings about the product, including not to push the needle slider forcibly, if you feel excessive resistance.
“Users of this device should note that for patients with abnormal symptoms or image findings post-procedure, the potential for unanticipated retained device components should be assessed,” Olympus said in a Sept. 19 notice to customers. “It is notable that some of these components are not radiopaque,” it added, meaning they cannot be spotted on X-rays.
Olympus has faced quality concerns in recent years, including the FDA sending multiple warning letters related to its endoscopes in 2023, MedTech Dive reported.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.