EchelonTM 145-5091-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00847536006256), received between Apr 13, 2017 and Sep 28, 2026 — classified as 2 deaths, 8 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (29 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 90 reports, 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 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 ↗
• 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 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 ↗
• MalfunctionDec 15, 2025Device Damaged by Another Device; Physical Resistance/Sticking; Device Damaged by Another Device; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED. THE COIL BECAME STUCK IN THE DISTAL SECTION OF THE CATHETER. IT WAS REMOVED FROM THE INTRODUCER SHEATH, AND IT IS UNKNOWN WHETHER THERE WAS ANY KINK OR DAMAGE TO THE COIL AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802911 ↗
• MalfunctionNov 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL TIP WAS DEFORMED AND EXPERIENCED RESISTANCE IN THE ECHELON CATHETER. THE PATIENT WAS UNDERGOING ANEURYSM INTERVENTIONAL EMBOLIZATION ON A RIGHT ANTERIOR CEREBRAL COMMUNICATING ARTERY SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 3.11 MM AND A 1.33 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 5.88 MM DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE ECHELON 10 MICROCATHETER WAS RAISED OVER A NERVE GUIDEWIRE. WHEN THE GUIDEWIRE REACHED THE DISTAL END OF THE MICROCATHETER, SIGNIFICANT RESISTANCE WAS FELT. AFTER IT WAS IN PLACE, AN AXIUM COIL WAS DELIVERED, BUT THE SPRING COIL COULD NOT BE DELIVERED OUT OF THE MICROCATHETER. RAISING THE INTERMEDIATE CATHETER AND APPLYING SOME TENSION DID NOT RESOLVE THE ISSUE. A NEW ECHELON 10 MICROCATHETER FROM THE SAME BATCH WAS USED, BUT THE PROBLEM PERSISTED, WITH SOME DEFORMATION AT THE AXIUM COIL TIP. A NEW MICROCATHETER AND A NEW COIL WERE USED AGAIN, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 23623547 ↗
• MalfunctionNov 21, 2025Difficult to Advance; Unintended Movement; Physical Resistance/Sticking; Difficult to Advance; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS ANTERIOR COMMUNICATING ARTERY (ACOMM), WITH 2MM DIAMETER.  IT WAS REPORTED THAT THE ECHELON CATHETER ENCOUNTERED RESISTANCE DURING DELIVERY AND EXPERIENCED DIFFICULTY WHILE NAVIGATING ON TRAXCESS GUIDEWIRE. THERE WAS NOT 1:1 PUSHABILITY. 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. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION WAS AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, SACCULAR IN SHAPE. THE GUIDEWIRE WAS ABLE TO PASS THE CATHETER HUB. NO DAMAGE FOUND TO THE CATHETER HUB. THE GUIDEWIRE TIP WAS SHAPED AS A SMALL C AT THE TIP. NO KINK DAMAGE FOUND ON THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED BY USING A PHENOM 17 WITH THE SAME WIRE. THE CATHETER HAD INTERMITTENT JUMPING DURING MANIPULATION. BASED ON THESE OBSERVATIONS, THE OPERATOR SUGGESTED THAT THERE MAY BE AN ISSUE WITH THE INNER COATING OF THE ECHELON CATHETER. ANCILLARY DEVICES INCLUDE A TRAXCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618804 ↗
• MalfunctionAug 8, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS KINKED. THE COIL GOT KINKED AND IT WAS HARD TO TAKE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED LOCATION WAS THE IMPLANT COIL. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE AN ECHELON 45, DO18661.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755344 ↗
• MalfunctionMay 13, 2025Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE DEVICE ISSUE WAS THE ECHELON GOT ENTRAPPED AND WAS DIFFICULT TO REMOVE. THE ECHELON DID NOT HAVE RESISTANCE IN THE GUIDE CATHETER, BUT THE NAVIEN USED HAD LOT NUMBER: D035317. THE ECHELON ALSO DID NOT HAVE RESISTANCE WITH A COIL. HOWEVER, 6 COILS WERE USED: 3 HELIX AND 3 3D. NO DAMAGE WAS OBSERVED TO THE ECHELON MICROCATHETER AFTER RETRIEVAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED BY USING AN ALTERNATIVE ECHELON: D022964.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013064 ↗
• MalfunctionJan 15, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AN ECHELON CATHETER TIP WAS DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY CLINOID SEGMENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 6.2MM. IT WAS REPORTED THAT DUE TO THE TORTUOUS VASCULAR PATH OF THE PATIENT, THE 6F-ENVOY DA+125CM MULTIFUNCTIONAL TUBE WAS PLACED AT THE LEVEL OF THE CAVERNOUS SINUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY WITH THE ASSISTANCE OF A 0.035IN GUIDEWIRE. THE BEST WORKING ANGLE WAS SELECTED, AND UNDER THE ROADMAP, A MICRO-GUIDEWIRE (SYNCHRO SOFT) WAS USED TO ASSIST THE MICRO-CATHETER (HEADWAY-21) TO BE PLACED AT THE DISTAL END OF THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY IN PREPARATION FOR STENT DEPLOYMENT, AND THE MICRO-GUIDEWIRE WAS WITHDRAWN. THE SAME MICRO-GUIDEWIRE WAS USED TO ASSIST THE MICRO-CATHETER (ECHELON 145-5091-150) TO BE PLACED INTO THE ANEURYSM. THE TIP OF THE MICRO-CATHETER WAS FOUND TO BE DAMAGED, SO A NEW MICRO-CATHETER 105-5091-150 WAS OPENED AND PLACED INTO THE ANEURYSM. THE MICRO-GUIDEWIRE WAS THEN REMOVED. THE TARGET 2.5/4 COIL WAS FILLED INTO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163137 ↗
• InjuryOct 23, 2024Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED AND THERE WAS CATHETER KICKBACK. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 1.78MM, AND THE NECK DIAMETER WAS .75MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT 8F VASCULAR SHEATH WAS USED TO PUNCTURE THROUGH THE FEMORAL ARTERY. WITH THE SUPPORT OF THE 0.035 LOACH GUIDEWIRE AND THE GUIDE-CATHETER, THE DELIVERY CATHETER WAS INTRODUCED INTO THE C1 SEGMENT OF THE INTERNAL CAROTID ARTERY. THE LOACH GUIDEWIRE AND THE GUIDE-CATHETER WERE WITHDRAWN. THE 0.014 GUIDEWIRE GUIDED THE 0.017 MICROCATHETER ECHELON 10 TO THE C7 SEGMENT, AND THE INTRACRANIAL SUPPORT CATHETER REACHED THE C5 OF THE INTERNAL CAROTID ARTERY THROUGH THE MICROCATHETER. THE 0.014 MICRO-GUIDEWIRE WAS GUIDED TO THE ANEURYSM NECK OF THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY, AND THE MICROCATHETER WAS GUIDED TO THE ANEURYSM NECK OF THE A2 SEGMENT THROUGH THE MICRO-GUIDEWIRE. THE DETACHABLE COIL WAS DELIVERED TO THE ANEURYSM NECK THROUGH THE MICROCATHETER. THE DETACHABLE COIL CAME OUT OF THE MICROCATHETER TO FO

  Patient problems: Cognitive Changes; Ischemia Stroke; Obstruction/Occlusion; Vasoconstriction

  MAUDE report 20518299 ↗
• MalfunctionOct 2, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ECHELON 10 MICROCATHETER THAT HAD RESISTANCE AND AN AXIUM COIL THAT HAD RESISTANCE IN THE SHEATH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT ANTERIOR COMMUNICATING (ACOM) ARTERY UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2.5MM. BLOOD FLOW WAS HIGH. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS DELIVERED WITH THE GUIDEWIRE. WHEN A COIL WAS BEING DELIVERED, THERE WAS RESISTANCE FELT IN THE MIDDLE SECTION OF THE MICROCATHETER. AFTER REPLACING THE MICROCATHETER, THE COIL DELIVERED NORMALLY. THEN A AXIUM COIL (MODEL: APB-2-4-HX-ES, LOT: 227097327) WAS SELECTED FOR FILLING. HOWEVER, IT WAS FOUND THAT THE COIL COULD NOT BE PUSHED OUT OF THE SHEATH. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO KINK/DAMAGE OBSERVED TO THE ECHELON MICROCATHETER THAT HAD RESISTANCE. THE MODEL AND LOT OF THE COIL THAT HAD RESISTANCE IN THE ECHELON MICRO CATHETER WAS APB-2-4-HX-ES LOT NO. 22

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353403 ↗
• MalfunctionSep 29, 2024Burst Container or Vessel; Burst Container or Vessel

  ON (B)(6) 2024 MPXR 1226034 (REP, HCP, FOR): MEDTRONIC RECEIVED INFORMATION THAT AN ECHELON CATHETER TIP BROKE. DURING THE ANEURYSM SURGERY THE ECHELON MICROCATHETER WAS PRE-SHAPED. THE TIP OF THE MICROCATHETER BROKE AND A NEW MICROCATHETER WAS REPLACED TO COMPLETE THE SURGERY. THE CATHETER WAS RUPTURED INTACT IN THE DISTAL LOCATION. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THERE WAS NO OTHER DAMAGE TO THE CATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM IN THE RIGHT FEMORAL ARTERY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330601 ↗
• MalfunctionSep 17, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT TWO ECHELON MICROCATHETERS WERE FOUND WITH DAMAGED TIPS. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 3.78 MM. IT WAS REPORTED THAT COIL EMBOLIZATION, AFTER THE ECHELON MICROCATHETER WAS SHAPED, IT WAS PUSHED TO GO UPPER UNDER THE GUIDANCE OF THE NERVE GUIDEWIRE AND ATTEMPTED TO BE PLACED INTO THE ANEURYSM CAVITY. DURING THE PLACEMENT PROCESS, IT WAS FOUND THAT THE TIP OF THE MICROCATHETER WAS OBVIOUSLY ABNORMALLY DEFORMED AND COULD NOT MAINTAIN ITS ORIGINAL SHAPE. THE MICROCATHETER WAS THEN WITHDRAWN AND IT WAS FOUND THAT THE TIP OF THE MICROCATHETER WAS DAMAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS BEING TREATED FOR A NARROW-NECKED ANEURYSM IN THE RIGHT CAVERNOUS SINUS SEGMENT, 4.5MM X 3.8MM. VESSEL TORTUOSITY WAS NORMAL. THE CAUSE OF THE CATHETER DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240018 ↗
• MalfunctionSep 17, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT TWO ECHELON MICROCATHETERS WERE FOUND WITH DAMAGED TIPS. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 3.78 MM. IT WAS REPORTED THAT COIL EMBOLIZATION, AFTER THE ECHELON MICROCATHETER WAS SHAPED, IT WAS PUSHED TO GO UPPER UNDER THE GUIDANCE OF THE NERVE GUIDEWIRE AND ATTEMPTED TO BE PLACED INTO THE ANEURYSM CAVITY. DURING THE PLACEMENT PROCESS, IT WAS FOUND THAT THE TIP OF THE MICROCATHETER WAS OBVIOUSLY ABNORMALLY DEFORMED AND COULD NOT MAINTAIN ITS ORIGINAL SHAPE. THE MICROCATHETER WAS THEN WITHDRAWN AND IT WAS FOUND THAT THE TIP OF THE MICROCATHETER WAS DAMAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS BEING TREATED FOR A NARROW-NECKED ANEURYSM IN THE RIGHT CAVERNOUS SINUS SEGMENT, 4.5MM X 3.8MM. VESSEL TORTUOSITY WAS NORMAL. THE CAUSE OF THE CATHETER DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239916 ↗
• MalfunctionAug 9, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE IN THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 4 MM AND A 2.8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PUSHING RESISTANCE OF COIL WAS LARGE AND COULDN'T BE PUSHED OUT. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE DISTAL SECTION OF THE CATHETER. THERE WAS NO CATHETER OR COIL DAMAGE OBSERVED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951693 ↗
• MalfunctionJul 17, 2024Break; Device Damaged by Another Device; Difficult to Advance; Material Deformation; Break; Device Damaged by Another Device; Difficult to Advance; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT A GUIDEWIRE CAME OUT OF THE DAMAGED TIP OF THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 5MM DIAMETER IT WAS REPORTED THAT AFTER THE CATHETER WAS STEAM-SHAPED, IT WAS INSERTED INTO THE GUIDING CATHETER TOGETHER WITH THE GUIDE WIRE. WHEN IT REACHED THE INTERNAL CAROTID ARTERY, IT WAS FOUND THAT THE GUIDE WIRE AND CATHETER WERE MOVING ABNORMALLY. AFTER WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE TIP OF THE MICROCATHETER WAS DAMAGED AND THE GUIDE WIRE CAME OUT FROM THE DAMAGED AREA. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760938 ↗
• MalfunctionJun 28, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ECHELON 10 MICROCATHETER THAT LEAKED AT THE HUB DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE VIA FEMORAL ACCESS. IT WAS REPORTED THAT THE DEVICE WAS PREPARED AND CATHETER FLUSH WAS ADMINISTERED PER THE INSTRUCTIONS FOR USE (IFU). THE ECHELON MICROCATHETER WAS SUCCESSFULLY NAVIGATED WITH THE GUIDEWIRE. AFTER THE Y-VALVE WAS LOCKED, THE SURGEON OBSERVED LEAKING AT THE ECHELON CATHETER HUB CONNECTION. THE ECHELON WAS WITHDRAW AND REPLACED WITH A NEW ECHELON 10 WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE CATHETER HUB LEAK WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638862 ↗
• MalfunctionJun 21, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE CATHETER CRACKS WERE NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583367 ↗
• MalfunctionJun 21, 2024Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE ECHELON CATHETER HAD BEEN 1-2CM AWAY FROM THE HEAT SOURCE FOR ABOUT 60 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583308 ↗
• MalfunctionMay 21, 2024Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE LEAK WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358596 ↗
• MalfunctionMay 20, 2024Leak/Splash; Physical Resistance/Sticking; Leak/Splash; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING STENT-ASSISTED SPRING COIL EMBOLIZATION, FLUID LEAKED FROM THE TIP OF THE ECHELON MICROCATHETER WHEN FLUSHING THE MICROCATHETER. THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION. THERE WERE CREASES AT THE DISTAL END OF THE NAVIEN. 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. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR STENT-ASSISTED ANEURYSM EMBOLIZATION. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 20MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352973 ↗
• MalfunctionMay 2, 2024Device Damaged by Another Device; Physical Resistance/Sticking; Device Damaged by Another Device; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CATHETER WAS PUNCTURED WITH THE GUIDEWIRE/STYLET IN THE DISTAL SECTION. THERE WAS FRICTION OR DIFFICULTY DURING INSERTION OF THE GUIDEWIRE/STYLET. THERE WAS NO OTHER DAMAGE ASIDE FROM THE PUNCTURE. THERE WAS NO KINK/DAMAGE ON THE GUIDEWIRE/PUSHWIRE/STYLET. 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 TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA) WITH A DIAMETER OF 3.5MM. ANCILLARY DEVICES INCLUDE A TRAXCESS 0.014 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229771 ↗
• MalfunctionApr 11, 2024Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE ECHELON CATHETER TIP WAS BROKEN AND DETACHED. THE PATIENT WAS UNDERGOING ANEURYSM COIL EMBOLIZATION. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.4 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER THE ECHELON MICROCATHETER WAS REMOVED, IT WAS FOUND THAT THE TIP END WAS BROKEN AND DETACHED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087021 ↗

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