The Recall Desk
HighFDA (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.

What this means for you

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.

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