The Recall Desk
HighFDA (Devices)·Z-2267-2023·Announced 2023-08-09

Olympus SPiN Drive Triple Needle Brush Recalled for Sensor Malfunction

Olympus Corporation recalls the Always-On Tip Tracked Triple Needle Brush due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing 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: This is a risk-of-harm medical device (FDA Class II) used in clinical interventions where sensor malfunction directly compromises critical navigation functionality during airway procedures. No illnesses or injuries have been reported, but the malfunction affecting procedural safety meets the rubric criterion for High severity.

Plain-English summary

Olympus Corporation of the Americas is recalling the Always-On Tip Tracked Instruments (SPiN Drive) Triple Needle Brush, Model INS-5300. This specialized instrument is intended for clinical interventions, particularly endobronchial procedures that rely on navigation guidance. Approximately 759.8 units are affected, with lot numbers 04617200805 and below. The device was distributed worldwide, including throughout the United States and internationally to China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan.

The recall addresses a malfunction in the electromagnetic (EM) sensor tracking system. This sensor failure impairs the navigation functionality that clinicians depend on during endobronchial procedures. When the malfunction occurs, the system alerts the user by generating a coil break warning message.

Healthcare providers using affected lots should discontinue use immediately. Olympus Corporation and the FDA provide additional information and instructions at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2267-2023. Patients or providers with questions about replacement instruments or safe alternatives should contact Olympus Corporation of the Americas directly.

The recalled product

Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model:
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Navigation Instrument
Hazard
  • electromagnetic-sensor-malfunction
  • navigation-failure
  • procedural-delay

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:00815686021207 Lot Number: 04617200805 and below

Distribution

Distributed nationwide across the United States.

Related recalls

Same category