Axium™ Detachable Coil System PC-3-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000488925), received between Nov 29, 2023 and Nov 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K203432); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AXIUM COIL PREPPED AND HYDRATED VERTICALLY PER FDA INSTRUCTION. DUE TO NON-TAPERED COIL SHEATH OF P C-3-8-HELIX A SMALL GAP EXISTS BETWEEN AXIUM COIL SHEATH AND ECHELON 10 MICROCATHETER ALLOWING THE COIL TO PREMATURELY BREAK CAUSING RESISTANCE ENOUGH FOR THE PHYSICIAN NOT BE ABLE TO ADVANCE COIL( KNOWN ISSUE). SECOND PC-3-8-HELIX PREPPED AND HYDRATED VERTICALLY PER FDA INSTRUCTION AND INSERTED INTO ECHELON 10 MICROCATHETER BUT SAME OCCURRENCE AS FIRST AXIUM DUE TO GAP CAUSED BY NON-TAPERED SHEATH CAUSING RESISTANCE AND UNABLE TO ADVANCE. INSERTED AN AXIUM PRIME 3-8-HX-ES WITH A TAPERED COILING SHEATH AND THE COIL DEPLOYED WITHOUT ISSUE. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN SHEATH. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SPINAL EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233609 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203432. One submission often covers many models, so check the product and lot details in each record.

• Z-1261-2022 · Apr 27, 2022 · Open, Classified
  AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;