Axium PrimeTM APB-2.5-4-HX-ESRecalls & reported problems
Micro Therapeutics, Inc. · COIL APB-2.5-4-HX-ES V04 · Class 2 · Implant
All models of Axium PrimeTM (66)
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 00847536032224), received between Aug 17, 2022 and Aug 17, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Physical Resistance/Sticking1
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.
MalfunctionAug 17, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THE A COIL PREMATURELY DETACHED IN THE MIDDLE OF THE CATHETER DURING DEPLOYMENT, AND ANOTHER COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ICA. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PUSHWIRE WAS NOT BENT OR BROKEN, AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY WITH THE COIL THAT PREMATURELY DETACHED. THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENT ATTEMPTS WERE MADE, AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THERE WAS NO DAMAGE TO THE CATHETER OR THE COIL THAT WAS STUCK IN THE MICROCATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT BOTH COILS DETACHED PREMATURELY. THE COIL WITH LOT: A943699 WAS STUCK IN THE MICROCATHETER. THE COILS DID NOT PUSH OUT OF THE INTRO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15241796 ↗
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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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