AxiumTM APB-3-6-3D-ES (UDI 00847536021891)Recalls & reported problems
Micro Therapeutics, Inc. · COIL APB-3-6-3D-ES V01 · Class 2 · Implant
All models of AxiumTM (139)
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 00847536021891), received between Apr 11, 2019 and Apr 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
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.
MalfunctionApr 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF A SMALL RUPTURED SACCULAR ANEURYSM LOCATED IN ANTERIOR COMMUNICATING ARTERY, MEASURING 4MMX2MM, THESE BOTH COILS FELT RESISTANCE WHILE PUSHING INSIDE THE HUB OF THE MICROCATHETER. EVEN THERE WAS A RESISTANCE WHEN PREPARING COILS ACCORDING TO IFU. THERE WAS ALSO SLIGHT RESISTANCE WHEN THE COILS WERE PUSHED FROM THE INTRODUCER SHEATH. THE PATIENT WAS ULTIMATELY TREATED WITH OTHER AXIUM COILS. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL WAS NORMAL TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8504043 ↗
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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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