EchelonTM 105-5092-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847536005983), received between Dec 21, 2018 and Sep 21, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 reports).

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

1 other recall cover devices cleared under the same FDA submission (K030688, 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-1557-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Device Damaged by Another Device

  Medtronic received a report that an Echelon microcatheter was perforated. It was reported that the Echelon microcatheter was used for aneurysm embolization. The package was opened and hydrated, and no issue was found with the microcatheter. The microcatheter was then shaped, and after shaping was successful, when advancing the micro guidewire, it was found that the guidewire perforated out near the distal marker point of the microcatheter. A new microcatheter was therefore requested, and the procedure continued. The catheter leak was observed at the distal end during preparation. The catheter was inspected or tested prior to use. The reported device and any accessory devices were prepared as indicated in the instructions for use (IFU). No patient symptoms or complications were associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837173 ↗
• MalfunctionJun 12, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE IN THE HUB OF AN ECHELON. THE PATIENT WAS UNDERGOING SURGERY FOR ANEURYSM TREATMENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS REPORTED THAT THE FIRST COIL GOT STUCK IN THE HUB OF THE ECHELON AND HAD BEEN STRETCHED. THE SECOND COIL GOT STUCK IN THE HUB. THERE WAS CATHETER OCCLUSION DURING COIL INTRODUCTION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED THAT THE COILS WERE STRYKER COILS. THE REPORT OF "CATHETER OCCLUSION" WAS REFERRING TO THE COILS BEING STUCK IN THE HUB. THE CAUSE OR CONTRIBUTING FACTOR FOR THE EVENT WAS IDENTIFIED WITH A PROBLEM IN THE JUNCTION BETWEEN MICRO AND HUB. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485852 ↗
• MalfunctionFeb 3, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING INTRODUCTION INTO TWO ECHELON 14 MICROCATHETERS, AN AXIUM COIL ENCOUNTERED RESISTANCE AND COULD NOT BE PUSHED INTO THE CATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF A CEREBRAL ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED: AXIUM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246105 ↗
• MalfunctionFeb 3, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING INTRODUCTION INTO TWO ECHELON 14 MICROCATHETERS, AN AXIUM COIL ENCOUNTERED RESISTANCE AND COULD NOT BE PUSHED INTO THE CATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF A CEREBRAL ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED: AXIUM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246096 ↗
• 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 22019920 ↗
• MalfunctionFeb 19, 2025Leak/Splash; Compatibility Problem; Material Deformation; Physical Resistance/Sticking; Leak/Splash; Compatibility Problem; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED DOCTORS IN THIS DEPARTMENT HAD FEW TIMES PROBLEMS WITH ECHELON, BUT THEY DIDN¿T REPORT IT. THE COIL COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. EVERYTHING WAS DONE AND INDICATED IN THE INSTRUCTUTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411498 ↗
• MalfunctionMar 14, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT AN ECHELON CATHETER RUPTURED. THE MICROCATHETER BROKE MAKING INSERTION IMPOSSIBLE. THE CATHETER WAS BROKEN. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542583 ↗
• MalfunctionSep 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED. DAMAGE WAS NOTICED AFTER OPENING THE PACKAGE. NO PREP WAS PERFORMED PRIOR TO THE DAMAGE BEING SEEN. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512567 ↗
• MalfunctionDec 8, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN TRYING TO INTRODUCE A NEUROFORM ATLAS STENT INTO THE ECHELON MICROCATHETER, THE STENT BECAME STUCK IN THE HUB. THE ECHELON WAS REMOVED AND REPLACED BY AN SL-10 MICROCATHETER, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A NEUROFORM ATLAS STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964089 ↗
• MalfunctionDec 21, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF COIL RESISTANCE IN THE PROXIMAL SECTION OF AN ECHELON CATHETER. PRIOR TO RESISTANCE, THE COIL HAD BEEN PUSHED FROM THE INTRODUCER SHEATH SMOOTHLY. THE DEVICES HAD BEEN PREPARED/FLUSHED AS INDICATED IN THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. THE ECHELON CATHETER WAS RETURNED AND OBSERVED TO HAVE PUNCTURE DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8192831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030688, K051990, K093750. One submission often covers many models, so check the product and lot details in each record.

• Z-1556-2022 · Jun 30, 2022 · Open, Classified
  Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only