EchelonTM 145-5092-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536006270), received between Oct 22, 2019 and May 14, 2025 — classified as 4 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K042187, K051990, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 30, 2022Class IIOpen, Classified

   Outer carton packaging of microcatheters were exposed to wet substance during transport.

   Z-1556-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Contamination /Decontamination Problem; Packaging Problem; Contamination /Decontamination Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE MATERIAL WAS WET. WHEN THE PACKAGE ARRIVED, THE PACKAGE WAS WET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019968 ↗
• MalfunctionMay 13, 2025Difficult to Remove; Material Deformation; Physical Resistance/Sticking; Difficult to Remove; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A TREATMENT FOR SUBARACHNOID HEMORRHAGE USING THE ECHELON 14 45° PRE-SHAPED TIP CATHETER, THE CATHETER ONLY ALLOWED ONE COIL TO BE IMPLANTED DUE TO EXCESSIVE RESISTANCE, PREVENTING THE CONTINUATION OF THE PROCEDURE. THE CATHETER WAS NOTED TO BE CRUSHED, KINKED, OR OTHERWISE DAMAGED, AND DID NOT ALLOW ANY ADDITIONAL COILS TO BE IMPLANTED. THERE WAS DIFFICULTY IN REMOVING THE CATHETER FROM THE VESSEL, AND IT APPEARED MALFORMED AFTER TWO IMPLANTS. THE PROCEDURE WAS SUSPENDED FOLLOWING THE CATHETER MALFUNCTION. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 4.0 MILLIMETERS AND MODERATE VESSEL TORTUOSITY. NO VASOSPASM OR SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009819 ↗
• MalfunctionAug 29, 2023Collapse; Collapse

  MEDTRONIC RECEIVED A REPORT THAT THE CATHETER TIP WAS DAMAGED. IT WAS REPORTED THAT THE CATHETER WAS CRUSHED AT THE DISTAL END. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN INTRACRANIAL ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7.6MM. ADDITIONAL INFORMATION RECEIVED THAT THE DAMAGE WAS NOT NOTICED UPON OPENING THE PACKAGE. HYDRATION WAS THE PREP PERFORMED PRIOR TO THE DAMAGE BEING SEEN. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641225 ↗
• MalfunctionOct 22, 2019Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE END BROKE WHEN THE ECHELON MICROCATHETER WAS PLACED INSIDE THE CATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN INTRACRANIAL ANEURYSM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9219858 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042187, K051990, 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