The Recall Desk
HighFDA (Devices)·Z-2266-2023·Announced 2023-08-09

Endobronchial Cytology Needles Recalled for Electromagnetic Sensor Malfunction

Olympus is recalling endobronchial navigation needles because an electromagnetic sensor malfunction can disable navigation guidance during medical 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 with an electromagnetic sensor malfunction affecting navigation guidance during procedures. No reported illnesses or injuries are documented in the source material. The recall is classified as FDA Class II without hospitalization reports, placing it in the High severity category per the rubric.

Plain-English summary

Olympus Corporation of the Americas is recalling Always-On Tip Tracked Instruments (SPiN Drive) 21-gauge endobronchial cytology needles. The recalled devices (model INS-0392, lot numbers 04991210310 and below) were distributed to healthcare facilities in the United States and internationally. Approximately 1,158 units are affected.

These needles contain an electromagnetic sensor that guides physicians during endobronchial procedures. A malfunction in the sensor can disable navigation tracking during the procedure, causing the system to display a coil break warning message. This malfunction may result in procedural delays.

The devices were distributed worldwide to the United States, China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan.

The recalled product

Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 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
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device
Hazard
  • sensor-malfunction
  • navigation-failure

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: 00815686020613 Lot Number: 04991210310 and below

Distribution

Distributed nationwide across the United States.

Related recalls

Same category