Acclarent, Inc. TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WV, WI, WY