Dive Brief:
- Olympus told customers last week to stop using certain lots of its ViziShot 2 FLEX needles due to the risk that components may detach during procedures.
- Olympus started the recall after receiving reports of patient injuries and one death. Olympus did not immediately respond to a request for comment, or specify how many injury reports it had received.
- The medtech company has faced quality concerns in recent years, with the Food and Drug Administration sending multiple warning letters to Olympus in 2023 related to its endoscopes, and blocking some of the devices from entering the U.S. in June.
Dive Insight:
Olympus’ ViziShot 2 FLEX needles are used in a minimally invasive procedure to diagnose or stage lung cancer. A physician uses an ultrasound to guide the needles and collect tissue samples.
The needles are protected by a hypotube, which provides stability during procedures, and a sheath. If the sheath has been damaged, the hypotube may eject from the device along with plastic components.
If components detach during a procedure, they may require bronchoscopic extraction or surgical removal, the company said. Olympus warned the components are not radiopaque, meaning they cannot be seen using X-rays.
Damage may occur during the manufacturing process, Olympus said. The company added that it has implemented an automated inspection procedure during assembly, while the devices had previously been inspected visually.
Olympus instructed customers to make sure they are not using devices from the affected lots, which were manufactured before May 12.
The FDA reposted Olympus’ alert on Monday. An FDA recall database entry from Sept. 5 said that Olympus first notified customers about the problem in an Aug. 6 letter. The recall applies to more than 103,000 units, according to the database entry.
Olympus has had other recent recalls related to its lung biopsy devices. Earlier this year, the company recalled endoscope guide sheath kits for a problem about the tip falling off in patients during surgery. Olympus received 26 reports of serious injuries, according to a recall notice posted by the FDA in March. Olympus also expanded a recall of bronchoscopes in 2024.
