EchelonTMRecalls & reported problems across all models

We found 5 models of EchelonTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 225 adverse event reports in the FDA's MAUDE database, received between Apr 13, 2017 and Sep 28, 2026 — classified as 3 deaths, 11 injuries, 211 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (68 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EchelonTM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 30, 2022Open, 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 ↗

2. Jun 30, 2022Open, 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 EchelonTM problems

EchelonTM models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EchelonTM 145-5091-150

  Catheter, continuous flush
  2 deaths90 reports
• EchelonTM 105-5091-150

  Catheter, continuous flush
  86 reports
• EchelonTM 105-5092-150

  Catheter, continuous flush
  1 recall10 reports
• EchelonTM 145-5092-150

  Catheter, continuous flush
  1 recall4 reports
• EchelonTM 190-5091-150

  Catheter, continuous flush
  1 death35 reports

Recent EchelonTM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925993 ↗
• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924272 ↗
• 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 ↗
• MalfunctionSep 17, 2026Break; Device Damaged by Another Device

  Medtronic received a report that the patient was undergoing treatment for aneurysm. It was noted that the patient's vessel tortuosity was unknown. The access vessel was the femoral artery, with unknown diameter.  It was reported that after hydration and while advancing the micro-guidewire into the microcatheter, the micro-guidewire was observed exiting through the sidewall near the Mark point at the microcatheter tip. The surgeon discovered a split at the microcatheter tip. The reported device and any accessory devices were prepared and flushed 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 50804335 ↗
• MalfunctionSep 9, 2026Compatibility Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692406 ↗
• MalfunctionJun 18, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AXIUM COIL ENCOUNTERED RESISTANCE WITH THE ECHELON 10 MICROCATHETER. THE COIL STRETCHED. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLISM SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, C7 INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 2.8 MM AND A 0.7 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.5 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS FOUND THAT THE COIL COULD NOT BE ADVANCED THROUGH THE MICROCATHETER, RESULTING IN THE COIL STRETCHED; AFTER REPLACING THE MICROCATHETER AND COIL WITH A DIFFERENT SET, THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT NO CAUSES OR CONTRIBUTING FACTORS FOR THE RESISTANCE OR COIL STRETCH WERE IDENTIFIED. NO ISSUES RESULTED IN THE DAMAGE THAT WAS FOUND. WHERE THE RESISTANCE IN THE CATHETER OCCURRED WAS ASKED BUT UNKNOWN. IT WAS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552241 ↗
• 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 ↗
• MalfunctionJun 4, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING COIL EMBOLIZATION, RESISTANCE WAS ENCOUNTERED IN THE PROXIMAL END OF THE ECHELON 10 MICROCATHETER (LOT D025959), PREVENTING COIL DELIVERY. THE MICROCATHETER WAS REPLACED WITH A NEWECHELON 10 (LOT D053242). RESISTANCE WAS ENCOUNTERED IN THE DISTAL END OF THE REPLACEMENT ECHELON MICROCATHETER. THE MICROCATHETER WAS REPLACED WITH A NON-MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. THE BARE AXIUM HELIX COIL (QC-5-15-HELIX) WAS REPORTED TO HAVE COIL RESISTANCE/STUCK IN SHEATH. THE AXIUM PRIME BARE COIL (APB-3-4-HX-ES) WAS REPORTED TO HAVE BECOME STUCK IN THE MIDDLE OF THE CATHETER. THE COILS WERE REPLACED WITH NON-MEDTRONIC PRODUCTS TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE OBSERVED TO THE COILS OR CATHETERS. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT CAVERNOUS SINUS ANEURYSM WITH A MAX DIAMETER OF 17 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ARTERIAL ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394292 ↗
• MalfunctionApr 27, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO AXIUM COILS THAT HAD RESISTANCE AND WERE DAMAGED DURING DELIVERY IN AN ECHELON 10 MICRO CATHETER. THE PATIENT WAS UNDERGOING HEPATIC ARTERY COIL EMBOLIZATION PROCEDURE VIA FEMORAL ARTERY ACCESS. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE ECHELON MICROCATHETER WAS IN PLACE AT THE TREATMENT LOCATION. THE FIRST COIL SELECTED QC-12-40-3D (LOT NUMBER: 230184266). AFTER THE COIL WAS PREPARED AND HYDRATED, RESISTANCE WAS FELT WHEN ADVANCING THE COIL IN THE MIDDLE SEGMENT OF THE ECHELON MICROCATHETER AND THE MIDDLE OF THE PUSHER BECAME KINKED. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER QC-12-40-3D COIL (LOT NUMBER: 230193615) WHICH WAS PREPPED AND HYDRATED. AGAIN, THERE WAS SIGNIFICANT RESISTANCE DURING DELIVERY. THE COIL STRETCHED IN THE MICROCATHETER. THE SYSTEM WAS THEM REPLACED AND THE PROCEDURE WAS COMPLETE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009448 ↗
• MalfunctionMar 18, 2026Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE, THE MICROGUIDE WAS INSERTED, AND UPON REACHING THE DISTAL SEGMENT OF THE ECHELON 10 90° PRE-SHAPED TIP MICROCATHETER, THE GUIDE CAME OUT THROUGH THE SIDE. THE MICROCATHETER WAS REMOVED, AND ANOTHER ECHELON 10 90° WAS USED WITHOUT INCIDENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, THE EVENT DID NOT LEADTO OR EXTEND PATIENT HOSPITALIZATION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL VESSEL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634049 ↗
• MalfunctionMar 16, 2026Leak/Splash; Device Damaged by Another Device; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE TERM ¿THROUGH-HOLE¿ DOES NOT REFER TO A DEVICE PUNCTURE, AND NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. ANEURYSM CHARACTERISTICS WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611715 ↗
• MalfunctionFeb 9, 2026Material Deformation; Poor Visibility

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN ANEURYSM AT THE LEFT OPHTHALMIC ARTERY SEGMENT AND WAS SCHEDULED FOR COIL EMBOLIZATION. AFTER FEMORAL ARTERY PUNCTURE AND ESTABLISHMENT OF THE ACCESS ROUTE, THE MICROCATHETER WAS ADVANCED, BUT THE DISTAL MARKER POINT WAS NOT VISIBLE UNDER FLUOROSCOPY. UPON WITHDRAWAL OF THE MICROCATHETER, IT WAS FOUND THAT THE MICROCATHETER WALL AT THE DISTAL MARKER POINT WAS DAMAGED. TO ENSURE SURGICAL SAFETY, A NEW MICROCATHETER WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. DAMAGE WAS AT THE DISTAL SECTION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR ANEURYSM EMBOLIZATION. ACCESS VESSEL WAS THE FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291664 ↗
• 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 ↗
• MalfunctionJan 16, 2026Retraction Problem; Compatibility Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT REGARDING AN ECHELON MICROCATHETER THAT HAD RESISTANCE AND WAS POSSIBLY DAMAGED BEFORE USE IN THE PROCEDURE. IT WAS REPORTED THAT THE ECHELON 10 MICRO CATHETER AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER HYDRATING THE ECHELON 10, THE SURGEON ATTEMPTED TO SHAPE THE CATHETER BUT FOUND THAT THE SHAPING NEEDLE WAS VERY DIFFICULT TO PULL OUT OF THE CATHETER. AFTER THE NEEDLE WAS PULLED OUT, REHYDRATION WAS PERFORMED. IT WAS FOUND THAT THE WATER FLOW THROUGH THE CATHETER WAS NOT SMOOTH. ADDITIONALLY, THE GUIDEWIRE COULD NOT ADVANCE SMOOTHLY. THE CATHETER WAS REPLACED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096024 ↗

Other Micro Therapeutics, Inc. products

• PipelineTM Flex Embolization Device with Shield TechnologyTM79 models · 1,020 reports
• AxiumTM139 models · 832 reports · 1 recall
• PIPELINE114 models · 622 reports · 1 recall
• Concerto Detachable Coil System34 models · 595 reports
• Axium Prime Detachable Coil System70 models · 497 reports
• ConcertoTM70 models · 436 reports
• Axium Detachable Coil System69 models · 288 reports
• Axium PrimeTM66 models · 237 reports