Agency classClass IIOur severity:High FDA (Devices)·Z-2269-2023·Announced 2023-08-09

SPiN Xtend Instruments Recalled for Electromagnetic Sensor Tracking Malfunction

Olympus Corporation is recalling 144 units of SPiN Xtend 2.0mm OD instruments (Model INS-5450) due to electromagnetic sensor tracking malfunction that impairs navigation during endobronchial procedures and may 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: Class II medical device with a malfunction affecting critical navigation functionality in clinical procedures, presenting a risk of procedural complications. No injuries or hospitalizations have been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 144 units of Always-On Tip Tracked Instruments (SPiN Drive instruments, SPiN Xtend 2.0mm OD, 21ga, Model INS-5450) used in clinical interventions and endobronchial procedures for computed tomography and endoscopic bronchoscopy visualization.

The recalled instruments are affected by an electromagnetic (EM) sensor tracking malfunction that impacts navigation functionality during endobronchial procedures. When the malfunction occurs, the system displays a coil break warning message, which may result in procedural delays.

The affected instruments have Lot Number 04541200528 and below (UDI-DI: 00815686020651). They were distributed worldwide to the United States (nationwide) and eight foreign countries: China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan. Healthcare facilities currently using these instruments should contact Olympus Corporation of the Americas for instructions on remedial actions.

The recalled product

Product: Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga 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 — Endoscopic/Bronchoscopic Instruments
Hazard: sensor-malfunction
navigation-impairment
Affected units: 144

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: 00815686020651 Lot Number: 04541200528 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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