Class 2 Device Recall Monarch, Aspirating Biopsy Needle

• Date Initiated by Firm: April 19, 2019
• Create Date: November 16, 2019
• Recall Status: Terminated on January 19, 2022
• Recall Number: Z-0025-2020
• Recall Event ID: 82763
• 510(K)Number: K173760
• Product Classification: Bronchoscope (flexible or rigid) - Product Code EOQ
• Product: Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
• Code Information: Lots: RS181129-1 RS181129-2 RS181210-1 RS181210-2 RS181210-3 RS181210-4 RS190117-1 RS190125-1 RS190211-1 RS190225-3 RS190308-1 RS190319-1
• Recalling Firm/ Manufacturer: AURIS HEALTH INC; 150 Shoreline Dr; Redwood City CA 94065-1400
• For Additional Information Contact: Joy M. Sacmar; 650-781-1610
• Manufacturer Reason for Recall: Reports of aspirating biopsy needle breakage
• FDA Determined Cause: Labeling design
• Action: On 04/19/19, Urgent Medical Device Notifications were mailed to customers. Customers were advised the following: Please review the updated instructions for use for proper insertion, along with updated and warnings/cautions related to the use of the device. Specifically, the following instructions were included: " Do NOT use excessive insertion force if resistance is encountered during insertion of the needle through the bronchoscope working channel. Excessive force may cause damage to either the device or the bronchoscope working channel. " DO inspect the needle sharp for damage prior to use. If damage is found, do not use the needle. " Do NOT use the needle if the bronchoscope working channel is damaged, kinked or compromised. Please ensure that all necessary personnel in your facility are made aware of this notification, and please maintain awareness on this notice to ensure effectiveness of the corrective action. Complete and return the Acknowledgement Form. Customers with questions are encouraged to call 1-800-434-0032. On 06/25/19, Urgent Medical Device Recall (Removal) notices were mailed to customers informing them that the recalling firm is in the process of investigating the root cause and they will contact customers when replacement product becomes available. In the meantime, refer to the Compatibility Statement in the User Manual when deciding to use other commercially available needles. Customers were advised: 1.Examine your inventory immediately to determine if you have product lots subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product lots subject to this recall (removal) and communicate the issue to relevant personnel, or anyone else in your facility who needs to be informed. 3. If any product lots subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. 4. Complete the attached Acknowledgement Form confirming receipt of this notice an
• Quantity in Commerce: 158
• Distribution: US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EOQ and Original Applicant = Auris Surgical Robotics, Inc.