FDA Medical Device Recalls (openFDA)
Acclarent, Inc.: TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
- Recall number
- Z-0824-2020
- Recalling firm
- Acclarent, Inc.
- Product
- TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
- Status
- Terminated
- Initiated
- 2019-03-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
- Root cause
- Device Design
- Action
- On 3/6/19, affected customers were contacted via Phone concerning the recall. On 3/12/19, the firm mailed a "Urgent Medical Device Recall" letter to affected customer via FedEx overnight. In addition to informing the customers about the recall, the letter asked customers to take the following actions: 1. Evaluate your current inventory of Acclarent TruDi Nav Suction Instruments with the identified lot numbers listed above. If you have inventory of the specific lots, DO NOT USE. Remove and return products immediately. 2. To return the products, complete BOTH customer acknowledgment and product return sections of the attached Business Reply Form (BRF)). A local Acclarent sales representative will contact you to retrieve the recalled products. Use the enclosed prepaid shipping label and attach a copy of the completed BRF with your product return. 3. Complete the BRF within three (3) business days of receipt even if you no longer have inventory of the identified products. Upon receipt of the completed BRF and your product return, your account will be credited. Incomplete BRFs cannot be processed. 4. Ensure that anyone in your facility who needs to be aware of this notification reads this letter carefully. 5. Maintain a copy of this communication where the inventory of the lots identified in this letter is located until all products are returned. 6. If you have product complaints or adverse events to report regarding the use of Acclarent products, please inform Acclarent by calling (650) 687-5888 7. For questions related to this issue and product recall, please contact your Acclarent sales representative or call (650) 687-5888
- Quantity
- 14 Suction Insstruments
- Distribution
- US: WI, IL, NE, CA, OH, NY OUS: None
- Lot, serial or model codes
- Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.
- 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