NA TN30RFLRecalls & reported problems
Medtronic Xomed, Inc. · BUR TN30RFL TRANSNASAL 3MM RND FLUTED · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994776235), received between Mar 18, 2019 and Mar 18, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K081475); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2019Material Separation; Material Separation
A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING A PROCEDURE, THE HEAD OF THE HANDPIECE WAS RELEASED. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8430152 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K081475. One submission often covers many models, so check the product and lot details in each record.
- Z-0961-2022 · Dec 15, 2021 · TerminatedSoftware 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E
- Z-0158-2022 · Aug 31, 2021 · Open, ClassifiedMedtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with
- Z-2085-2016 · May 13, 2016 · TerminatedSaw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number:
Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices
- RemB 6400034000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,618 reports
- NA XMAXAnspach Effort, The · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,225 reports
- NA EG1ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE859 reports
- NA CRANI-ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall772 reports
- NA 5450400000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE775 reports
- NA 05.001.010Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE770 reports
- RemB 6400015000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE603 reports
- NA QD11Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE580 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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