Agency classClass IIOur severity:High FDA (Devices)·Z-2262-2023·Announced 2023-08-09

Bronchoscopy Instruments Recalled for Electromagnetic Sensor Tracking Malfunction

Olympus Corporation is recalling Always-On Tip Tracked Instruments due to a malfunction in the electromagnetic sensor that impairs navigation functionality during bronchoscopic procedures. The malfunction could result in procedural delays.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The malfunction affects critical navigation function during invasive procedures, making this a risk-of-harm product. Per the rubric, risk-of-harm devices where injury has not yet been reported score as High (3). No illnesses or deaths have been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling Always-On Tip Tracked Instruments (SPiN Drive instruments), specifically Brush models (15mm length, 1.8mm outer diameter, Model INS-0352). These instruments are designed for use in clinical interventions where computed tomography and/or endoscopic bronchoscopy are used for visualization. Approximately 1,816.2 units have been distributed worldwide.

The electromagnetic (EM) sensor that tracks the instruments' position can malfunction, impairing navigation functionality during endobronchial procedures. When the malfunction occurs, the system reports a coil break warning message. This could result in a potential procedural delay.

The recalled lot numbers are 04865230201 and below (UDI-DI: 00815686020538). Distribution includes the United States and overseas locations in China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan.

The recalled product

Product: Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Bronchoscopy / Surgical Instruments
Hazard: sensor-malfunction
navigation-impairment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI-DI: 00815686020538 Lot Numbers: 04865230201 and below

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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