Class 2 Device Recall TruDi NAV Suction Instruments

• Date Initiated by Firm: November 12, 2021
• Create Date: December 22, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0415-2022
• Recall Event ID: 89170
• 510(K)Number: K180948
• Product Classification: Ear, Nose, and Throat Stereotaxic Instrument - Product Code PGW
• Product: TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
• Code Information: 0-Degree Lots: 1903120, 1903250, 1904060, 1904180, 1904240, 1905030, 1905070, 1906260, 1907120, 1907170, 1907220, 1907240, 1907260, 2003040, 2009110, 2011240, 2102080, 2103090, 2104260, 2105040, 2105260, 2106100, 2107070. 70-Degree Lots: 1903137, 1903257, 1904067, 1905017, 1905037, 1905077, 1906067, 1906267, 1907127, 1908137, 1908157, 2003127. 90-Degree: 1903139, 1903259, 1904069, 1905019, 1905139, 1906079, 1908269, 1909279, 1909309, 1910299, 2003029, 2004029
• Recalling Firm/ Manufacturer: Acclarent, Inc.; 31 Technology Dr Suite 200; Irvine CA 92618-2346
• For Additional Information Contact: 949-784-9350
• Manufacturer Reason for Recall: Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
• FDA Determined Cause: Process control
• Action: On 11/12/21, recall notices were sent to OR Directors, Risk Managers, or Material Managers. Customers were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2) Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3) If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4) Complete the Business Reply Form and return to acclarent8930@sedgwick.com 5) After the Business reply Form is received a return kit will be sent. 6) Keep this notice visibly posted for awareness until all product subject to this recall has been returned. Customers with additional questions are encouraged to call the recalling firm at 1-877-775-2789, 4:00am-5:00pm PST.
• Quantity in Commerce: 1543
• Distribution: US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV, CA, NJ, UT, AL, MA, WI, TN, WV, OH, NC, KY, HI¿, OK, GA, CO, MO, WY, MS, NH, HI, MD, ID
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PGW and Original Applicant = Acclarent, Inc.