Medical device manufacturer Olympus has initiated a Class I recall of its endoscope guide sheath kits after receiving multiple reports of serious injuries associated with the products. The Food and Drug Administration (FDA) has classified this as the most severe type of recall due to potential health risks, including bleeding and other complications. Olympus has discontinued these products in the U.S. market and is now removing them entirely. The recall involves specific models used for collecting lung tissue samples, which have experienced issues with their radiopaque tips detaching during procedures.

Recalled Devices and Potential Risks

The recall encompasses several single-use guide sheath kits used in conjunction with Olympus endoscopes. These devices assist healthcare professionals in obtaining cell and tissue samples from lung regions. Reports indicate that the radiopaque tip of these sheaths has detached during surgeries, leading to 26 serious injuries. Although no deaths have been reported, the FDA warns of significant adverse health consequences. Immediate cessation of use has been advised by Olympus, along with product returns for credit.

Between July 2021 and January 2025, Olympus received 32 complaints regarding the detachment of the sheath's tip during surgical procedures. The company issued an urgent medical device removal notice in January, informing customers about the potential risks. The separation of the tip could necessitate additional medical interventions to remove it from patients, causing delays or cancellations of procedures. Olympus' investigation suggests that excessive force during instrument insertion or damage to the distal end of the sheath may be contributing factors to this issue.

Market Removal and Future Focus

Olympus has taken decisive action by discontinuing the affected models in the U.S. market and focusing on its next-generation sheath designs. The company aims to address the safety concerns raised by the recalled devices through improved technology. Customers are encouraged to return the recalled products for credit, ensuring a smooth transition to newer models.

This recall follows less than 18 months after Olympus ceased selling electromagnetic navigation systems used for lung biopsies. Acquired through a $300 million purchase of Veran Medical Technologies, these systems faced quality issues that led to a suspension of shipments and subsequent recalls. Olympus is now concentrating on its advanced K-401 and K-402 sheath models, which feature a redesigned radiopaque tip to enhance safety and reliability. The company remains committed to improving patient outcomes and addressing any emerging concerns in its product lineup.