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U.S. Department of Health and Human Services

Class 2 Device Recall TruDi Navigation System

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  Class 2 Device Recall TruDi Navigation System see related information
Date Initiated by Firm September 21, 2023
Date Posted October 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-0127-2024
Recall Event ID 93087
510(K)Number K192397  
Product Classification Ear, Nose, and Throat Stereotaxic Instrument - Product Code PGW
Product TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Code Information TruDi Navigation System, UDI-DI: 10846835018639, software version: V2.3.1 Update (2.3.1.144 and 2.3.1.166)
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		 When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.
FDA Determined
Cause 2		 Software Design Change
Action On 9/21/23, correction notices were mailed to customers who were asked to do the following: Please cease using the affected curette device with the affected navigation system until the new version of navigation system software version 2.3.2 is installed. 2. Please do not return any of the curettes within your inventory. 3. Complete and return the business response form via email to OneMD-Field-Actions@its.jnj.com 4. Forward this notice to any personnel in your facility that needs to be informed. 5. If any of the affected products have been forwarded to another facility, contact that facility and provide a copy of this to the relevant personnel. 6. Post a copy of this notice in a visible area for awareness If any adverse reactions or quality problems are experienced during the use of the affected navigation system with the curette, please report any issues to the firm via the product complaint phone number:1-877-775-2789, Option # 5.
Quantity in Commerce 141
Distribution US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME, SC, NC, CT, DC, MN, LA, OK, PA, AL, IA, MI, SD
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 = Biosense Webster
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