Onyx 34 105-7100-080 (UDI 00836462005051)Recalls & reported problems
Micro Therapeutics, Inc. · Liquid Embolic 105-7100-080 Onyx 34 · Class 3 · Implant
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 00836462005051), received between Mar 19, 2022 and Mar 19, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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
- Display or Visual Feedback Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem
MEDTRONIC RECEIVED INFORMATION THAT AN ONYX HAD POOR VISUALIZATION. THERE WAS NO PATIENT ASSOCIATED WITH THIS EVENT. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. IN THE CASE OF ARTERIOVENOUS MALFORMATION (AVM), ONYX WAS INJECTED FROM THE INFLOW BLOOD VESSEL, BUT THE VISIBILITY WAS POOR, SO IT WAS REPLACED WITH A NEW ONE. SETTING SPEED OF MIXING WAS 8. MIXING TIME WAS MORE THAN 20 MINUTES. THE ONYX VIALS DID NOT SIT MORE THAN 5 MINUTES PRIOR TO INJECTION. CONTINUED MIXING UNTIL IMMEDIATELY BEFORE USING THE ONYX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13816591 ↗
Other Agent, injectable, embolic devices
- Apollo 105-5096-000Micro Therapeutics, Inc. · Agent, injectable, embolic83 reports
- ApolloTM 105-5096-000Micro Therapeutics, Inc. · Agent, injectable, embolic64 reports
- ONYX 18 105-7100-060Micro Therapeutics, Inc. · Agent, injectable, embolic1 death43 reports
- ApolloTM 105-5095-000Micro Therapeutics, Inc. · Agent, injectable, embolic34 reports
- Apollo 105-5095-000Micro Therapeutics, Inc. · Agent, injectable, embolic18 reports
- Onyx 18 105-7100-060Micro Therapeutics, Inc. · Agent, injectable, embolic15 reports
- ONYX 34 105-7100-080Micro Therapeutics, Inc. · Agent, injectable, embolic10 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 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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