The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2268-2023·Announced 2023-08-09

SPiN Drive Needle Navigation Sensor Malfunction Triggers Procedural Delays

Olympus SPiN Drive needles have an electromagnetic sensor tracking malfunction that impairs navigation during endobronchial clinical procedures. Affected devices may generate false coil break warnings and cause 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: FDA Class II medical device with functional sensor malfunction that impairs critical navigation capabilities during clinical procedures. No injuries have been reported, but the malfunction creates risk of harm through procedural delays and compromised navigation guidance, qualifying as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling Always-On Tip Tracked Instruments (SPiN Drive instruments, Model INS-5410), which are 22-gauge SPiN Flex Needles with 1.8mm outer diameter and 12mm length. These instruments are used for clinical interventions in anatomical structures where computed tomography and endoscopic visualization are used for guidance. The recall involves approximately 1,908 units due to an electromagnetic sensor tracking malfunction.

The sensor tracking malfunction impairs the navigation functionality during endobronchial procedures. When the malfunction occurs, the system generates a coil break warning message and may cause procedural delays.

These instruments were distributed worldwide, including nationwide in the United States and to China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan. Affected units are identified by lot number 06332230201 and below.

Healthcare providers and clinical facilities using these instruments should contact Olympus Corporation of the Americas for further instructions regarding this recall.

The recalled product

Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex 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 — Endoscopic Navigation Device
Hazard

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: 00815686020637 Lot Number: 06332230201 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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