Olympus recalls faulty lung biopsy devices and expands GI endoscopy portfolio

JAPAN – Global medical technology company Olympus has issued a Class I recall for its endoscope guide sheath kits after receiving reports of 26 serious injuries linked to the devices.

The U.S. Food and Drug Administration (FDA) classified the recall as the most serious type, warning that the faulty sheaths could lead to bleeding, severe complications, and potential death if not addressed.

The recall affects Olympus’ K-201, K-202, K-203, and K-204 single-use guide sheath kits, which help physicians collect tissue samples from the lungs using Olympus endoscopes.

These sheaths have a radiopaque tip, allowing doctors to visualize the device on an X-ray monitor.

However, Olympus received 32 complaints between July 2021 and January 2025 about the tip detaching inside patients during procedures, leading to 26 injuries and six malfunctions.

In January, Olympus sent an urgent device removal notice, instructing healthcare providers to immediately stop using the affected models.

The company acknowledged that medical interventions may be needed to remove detached tips, potentially causing delays or cancellations of procedures.

Olympus’ investigation suggested that excessive force during insertion might be the cause of the tip detachment. Damage to the sheath’s distal end, where the tip is attached, could also be a contributing factor.

“Olympus takes patient safety seriously,” the company stated. “We are working closely with healthcare facilities to remove affected products and transition to our next-generation sheaths.”

The recall follows Olympus’ discontinuation of these products in the U.S. in 2022, as the company shifts focus to its new K-401 and K-402 sheath models, which feature an improved tip design.

New Hemostasis clip to enhance GI endoscopy procedures

While addressing the recall, Olympus is also expanding its gastrointestinal (GI) endoscopy portfolio with the launch of the Retentia HemoClip in the U.S.

The single-use clip is designed to control bleeding during endoscopic procedures and features a 360° rotation system for precise placement.

Mike Callaghan, Global VP and General Manager for EndoTherapy at Olympus, emphasized the device’s importance: “As procedural needs in GI endoscopy evolve, our solutions must keep up. The Retentia HemoClip enhances procedural success with easy deployment and a broad range of size options.”

Key features of the Retentia HemoClip include:

• Three arm lengths (9mm, 12mm, and 16mm) to accommodate different closure needs.
• A short tail length for better visibility of the target site, making it easier to place multiple clips.
• Sheath markings to assist in insertion and removal.
• A one-step deployment system for efficient use.

The Retentia HemoClip is part of Olympus’ broader EndoTherapy portfolio, which includes advanced tools for endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD)—techniques used to remove cancerous and abnormal tissues from the digestive tract.

Despite the recall, Olympus continues to innovate in endoscopic procedures. The company has developed advanced hemostatic technologies, such as:

• Red Dichromatic Imaging (RDI), part of the EVIS X1 endoscopy system, which enhances the visibility of deep blood vessels compared to standard white light.
• EndoClot Polysaccharide Hemostatic Spray (PHS), a powder-based hemostat used in combination with conventional bleeding control methods like clips.