FDA Medical Device Recalls (openFDA)
Acclarent, Inc.: TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
- Recall number
- Z-0415-2022
- Recalling firm
- Acclarent, Inc.
- Product
- TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
- Status
- Open, Classified
- Initiated
- 2021-11-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root 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
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K180948"]
- PMA numbers
- not on file
- Product code
- PGW
- Firm FEI
- 3005172759
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28