NICO Myriad NN-7000Recalls & reported problems
Nico Corporation · Console · Class 2
All models of NICO Myriad (16)
Data updated Oct 18, 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 00816744027001), received between May 15, 2019 and May 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Circuit Failure” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Circuit Failure1
- Electrical /Electronic Property Problem1
- Intermittent Continuity1
Patient problems
- 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.
MalfunctionMay 15, 2019Circuit Failure; Intermittent Continuity; Electrical /Electronic Property Problem; Circuit Failure; Intermittent Continuity; Electrical /Electronic Property Problem
NO PATIENT INJURY OCCURRED AS A RESULT OF THIS PRODUCT PROBLEM. THE MYRIAD SYSTEM PRIMARILY CONSISTS OF A SINGLE USE DISPOSABLE HANDPIECE, A CONSOLE, AND A FOOT PEDAL. THE CONSOLE AND FOOT PEDAL ARE USED TO CONTROL THE HANDPIECE. THE HANDPIECE IS USED TO ASPIRATE AND/OR CUT AND REMOVE FLUIDS AND TISSUES. THE MYRIAD SYSTEM HAS TWO MODES OF OPERATION: 1) SUCTION ONLY 2) SUCTION WITH CUTTING. SUCTION IS GENERATED WITHIN THE CONSOLE AND IS DELIVERED TO THE HANDPIECE USING THE FOOT PEDAL. WHEN THE MAIN FOOT PEDAL IS DEPRESSED, SUCTION IS INITIATED. WHEN THE MAIN FOOT PEDAL IS RELEASED, SUCTION CEASES. THE FOOT PEDAL ENABLES SUCTION TO BE DELIVERED THROUGH A SERIES OF ELECTRICAL CONNECTIONS. THE FOOT PEDAL IS PLUGGED INTO A RECEPTACLE ON THE CONSOLE AND DELIVERS SIGNALS TO THE MAIN PCB, WHICH IN TURN COMMUNICATES WITH VARIOUS PNEUMATIC COMPONENTS VIA A WIRE HARNESS (I.E., AN ELECTRIC CABLE). THE DEVICE PROBLEM WHICH WAS IDENTIFIED ON (B)(6) 2019 INVOLVED AN INTERMITTENT ELECTRICAL CONNECTION BETWEEN A WIRING HARNESS AND THE MAIN PCB BOARD WITHIN THE CONSOLE. SPECIFICALLY, THE INTERMITTENT CONNECTION RESULTED IN TWO FAILURE MODES: 1) DURING DEPRESSION OF THE FOOT PEDAL (I.E., SIGNALING TO
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8612988 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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