Echelon 105-5092-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836462002258), received between Jan 14, 2025 and Jan 14, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K093750); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL FAILED TO RESHEATH.   THE AXIUM COIL WAS USED AS THE FIRST COIL FOR THE EMBOLIZATION OF AN ANEURYSM. AFTER REWINDING THE PRODUCT SEVERAL TIMES, THE TIP OF THE COIL COULD NO LONGER BE RESHEATHED INTO THE CATHETER, AND THE CATHETER HAD TO BE COLLECTED. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS NOT REPOSITIONED. THE TIP OF THE COIL WAS WOUND IN A LOOP SEVERAL MILLIMETERS SMALLER THAN THE ORIGINAL SHAPE AND WAS WOUND SEVERAL TIMES IN A HELICAL SHAPE. THERE WERE NO ABNORMALITIES OR BREAKAGE IN THE CONCOMITANT CATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. LESION CHARACTERISTICS INCLUDED "A-COM 5MM." V ESSEL TORTUOSITY WAS NORMAL. THE REPORTED PRODUCT WAS COLLECTED AND REPLACED TO COMPLETE THE PROCEDURE. THE CAUSE OF THE AXIUM COIL FAILURE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149376 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093750. One submission often covers many models, so check the product and lot details in each record.

• Z-1557-2022 · Jun 30, 2022 · Open, Classified
  Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
• Z-1556-2022 · Jun 30, 2022 · Open, Classified
  Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only