EchelonTM 105-5091-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00847536005969), received between Oct 9, 2018 and Jun 18, 2026 — classified as 3 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (28 reports).

2 other recalls cover devices cleared under the same FDA submission (K031992, 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 86 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 29, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSES OF THE CATHETER PERFORATION, RESISTANCE, AND COIL DAMAGE WERE NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. AFTER REMOVAL, THE SHAPE OF THE SPRING COIL WAS OBSERVED TO BE IRREGULAR. NO ISSUES WERE IDENTIFIED THAT RESULTED IN THE DAMAGE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905326 ↗
• MalfunctionNov 26, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE GUIDEWIRE WAS ABLE TO PASS THROUGH THE CATHETER HUB WITHOUT ISSUE, AND NO DAMAGE WAS OBSERVED TO THE CATHETER HUB. THE GUIDEWIRE TIP HAD BEEN SHAPED PRIOR TO USE. NO KINK OR DAMAGE WAS FOUND ON THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660807 ↗
• MalfunctionNov 24, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN INTERNAL CAROTID ARTERY ANEURYSM. THE SURGEON SUSPECTED A PROBLEM WITH THE MATERIAL AT THE TIP OF THE MICROCATHETER CAUSED THE EVENT. THE GUIDEWIRE USED WAS NOT A MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631823 ↗
• MalfunctionJul 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN ATTEMPTING TO INSERT COILS FROM OTHER MANUFACTURERS, NONE COULD PASS THROUGH THE HUB, MAKING IT NECESSARY TO SWITCH TO A MICROCATHETER FROM ANOTHER MANUFACTURER. SINCE WIRE INSERTION AND EXCHANGE WERE REQUIRED, THE PRODUCT IN QUESTION WAS CUT DUE TO LENGTH CONSTRAINTS. THE ISSUE WAS WITH THE HUB PORTION, SO IT IS REQUESTED THAT THE CUT PORTION BE EXCLUDED FROM THE ANALYSIS. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE CATHETER WAS WETTED ACCORDING TO THE INSTRUCTIONS IN THE ACCOMPANYING DOCUMENTATION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE RESISTANCE WAS AN ISSUE WITH THE HUB AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669189 ↗
• MalfunctionMay 23, 2025Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED DIFFICULT PLACEMENT. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED RIGHT MCA BIFURCATION ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 4.3 MM AND NECK DIAMETER 2.4 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. PHYSICIAN DECIDED TO TREAT A RUPTURED WIDE NECK RIGHT MCA BIFURCATION ANEURYSM WITH BALLOON ASSISTED COILING. CONSIDERING THE MEASUREMENTS OF ANEURYSM, HE DECIDED TO TAKE THIS AS 1ST COIL. BUT HE WAS UNABLE TO DEPLOY THIS COIL DUE TO MORPHOLOGY OF THE ANEURYSM EVEN WITH BALLOON INFLATION ALSO. THIS COIL WAS NOT FITTING INSIDE THE ANEURYSM AT ALL DUE TO 15CM LENGTH, SO HE TOOK OUT THIS COIL <(>&<)> DEPLOYED FC-4-10-3D AS 1ST COIL WHICH FRAMED NICELY. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. THERE WERE NO ADDITIONAL STEPS/SURGICAL INTERVENTIONS REQUIRED TO REMOVE OR SECURE THE COIL. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS NOT UNDER STRESS. THE TIP OF THE CATHETER MOVED DURING DEPLOYMENT. THE PHYSIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077247 ↗
• MalfunctionMay 2, 2025Break; Leak/Splash; Break; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE ECHELON BREAK/LEAK WAS NOT DETERMINED. THE BREAK WAS REFERRING TO A LEAK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MICROCATHETER. IT WAS NOTED THAT COILING WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949402 ↗
• MalfunctionApr 23, 2025Leak/Splash; Material Deformation; Physical Resistance/Sticking; Leak/Splash; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DEFINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894956 ↗
• MalfunctionJan 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE ECHELON CATHETER ENCOUNTERED RESISTANCE WITH A STRYKER COIL. THE PATIENT WAS UNDERGOING ANEURYSM COIL EMBOLIZATION. THE ACCESSED VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 4.7 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE 6F-GUIDE CATHETER WAS GUIDED TO THE HORIZONTAL SEGMENT OF THE LEFT PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY WITH THE ASSISTANCE OF A 0.035IN GUIDEWIRE. THE BEST WORKING ANGLE WAS SELECTED, AND THE MICROCATHETER 105-5091-150 WAS GUIDED INTO THE ANEURYSM BODY WITH THE ASSISTANCE OF A MICRO-GUIDEWIRE SYNCHRO UNDER THE ROADMAP. THE MICRO-GUIDEWIRE WAS WITHDRAWN, AND THE ANEURYSM WAS FILLED WITH THE TARGET2/3 COIL, BUT IT WAS FOUND THAT IT COULD NOT BE FILLED. THE SURGEON SUSPECTED THAT IT WAS A PROBLEM WITH THE MICROCATHETER. SO, A NEW MICROCATHETER WAS UNPACKED, AND THE COIL WAS SUCCESSFULLY FILLED. TRANSCATHETER ANGIOGRAPHY SHOWED THAT MOST OF THE ANEURYSM WAS EMBOLIZED AT RAYMOND III LEVEL, THE COIL WAS WELL POSITIONED, THE PARENT ARTERY WAS UNOBSTRUCTED, AND NO OBVIOUS ABNORMALITIES WERE FOUND IN THE DISTAL BLOOD VESSEL. XPER-CT SHOWED NO OBVIOUS BLEEDING, AND THE OPER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152591 ↗
• MalfunctionNov 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SPRING COIL COULD NOT PASS THROUGH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS REPORTED THAT DURING THE OPERATION, THE SURGEON PUSHED THE SPRING COIL THROUGH THE MICROCATHETER, BUT IT DIDN'T MOVE. AFTER REPLACING THE SPRING COIL WITH ANOTHER ONE, IT STILL FAILED. FINALLY, THE SURGEON REPLACED THE MICROCATHETER WITH ANOTHER ONE, AND THE SPRING COILS WERE PUSHED THROUGH SMOOTHLY. 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. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. THE COILS CAME OUT OF THE INTRODUCER SHEATHS SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622251 ↗
• MalfunctionAug 26, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT AN ECHELON10 CATHETER SEPARATED. DOCTOR WAS ABOUT TO PUSH THE 4TH ONYX 34 TO THE ECHELON AND IT SUDDENLY BROKE PROXIMALLY. NO PROBLEMS WERE ENCOUNTERED WITH THE 1ST TO 3RD ONYX BUT ON THE 4TH ONE, THE MICROCATHETER BROKE PROXIMALLY. IT SEPARATED DURING USE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE CATHETER TIP WAS NOT ENTRAPPED OR STUCK. THE CAHETER WAS NOT STUCK IN THE GUIDECATHETER. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. IT BROKE IN THE PROXIMAL SECTION. THE BROKEN HALF OF THE CATHETER REMAINS IN THE FEMORAL ARTERY OF THE PATIENT. THE PATIENT IS STABLE WITH NO COMPLICATIONS.  THE PATIENT WAS UNDERGOING LIQUID EMBOLIZATION. VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA).

  Patient problems: Foreign Body In Patient

  MAUDE report 20072830 ↗
• MalfunctionAug 8, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT DURING AN AVM SURGERY, THE PATIENT NEEDED TO BE INJECTED WITH ONYX18. WHEN FLUSHING THE MICROCATHETER, WATER LEAKAGE WAS FOUND AT THE TIP. A NEW MICROCATHETER WAS THEN REPLACED. THE CATHETER HAD BEEN INSPECTED OR TESTED PRIOR TO USE. THERE WERE NO SYMPTOMS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED PER IFU. VESSEL TORTUOSITY WAS NORMAL. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.8MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939160 ↗
• MalfunctionJul 22, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging

  MEDTRONIC RECEIVED A REPORT THAT THE MARKER BAND WAS NOT VISIBLE ON THE ECHELON CATHETER WHEN OPENING FROM THE PACKAGE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT WHEN TREATING AN INTRACRANIAL ANEURYSM, A MICRO GUIDEWIRE WAS USED TO BRING THE MICROCATHETER TO THE LESION. WHEN UNSEALING THE ECHELON 10 MICROCATHETER, THE SURGEON FOUND THAT THE DISTAL MARKER POINT OF THE MICROCATHETER COULD NOT BE SEEN (NORMALLY IT COULD BE SEEN OUTSIDE THE BODY), SO DARE NOT USE IT, RETURNED IT TO THE MANUFACTURER FOR EVALUATION, REUSED ANOTHER BRAND OF MICROCATHETER, AND PUSHED THE MICROCATHETER TO GO UPPER TO COMPLETE THE OPERATION. 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. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19800521 ↗
• MalfunctionJul 16, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE LESION CHARACTERISTICS: INTERNAL CAROTID ARTERY (ICA), WIDTH OF 4 MM, AND A 2MM NECK DIAMETER; SACCULAR. THE CAUSE OF THE CATHETER PUNCTURE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751038 ↗
• MalfunctionJul 16, 2024Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT THE GUIDEWIRE/STYLET PUNCTURED THE DISTAL SECTION OF THE ECHELON CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE INTERNAL CAROTID ARTERY WITH A DIAMETER OF 4 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT PUNCTURED ECHELON MICROCATHETER IN TIP COIL. IT WAS REPORTED THAT CATHETER PUNCTURE GUIDEWIRE/STYLET) OCCURRED IN THE DISTAL SECTION. THERE WAS NO FRICTION OR DIFFICULTY DURING INSERTION OF THE GUIDEWIRE/STYLET. ASIDE FROM THE PUNCTURE, THERE WAS NO OTHER DAMAGE TO THE CATHETER. THERE WAS NO KINK OR DAMAGE ON THE GUIDEWIRE/PUSHWIRE/STYLET. 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 19751017 ↗
• MalfunctionJun 27, 2024Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE ECHELON CATHETER RUPTURED DURING USE. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SURGEON PERFORMED ANEURYSM EMBOLIZATION AND SELECTED THE ECHELON MICROCATHETER. AFTER OPENING THE OUTER PACKAGING OF THE MICROCATHETER, IT WAS INTACT. AFTER THE SHAPING WAS COMPLETED, THE GUIDE WIRE ENTERED THE MICROCATHETER AND FOUND THAT THE TIP OF THE MICROCATHETER WAS BROKEN AND THE GUIDE WIRE PASSED OUT OF THE MICROCATHETER. SO, A NEW ECHELON MICROCATHETER WAS REPLACED AND THE OPERATION WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THE CATHETER RUPTURED (INTACT) IN THE DISTAL SECTION. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. ASIDE FROM THE RUPTURE THERE WAS NO OTHER DAMAGE TO THE CATHETER. 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 19624152 ↗
• MalfunctionJun 21, 2024Collapse; Material Deformation; Collapse; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE ECHELON CATHETER WAS CRUSHED. THE PATIENT WAS UNDERGOING AN ANEURYSM EMBOLIZATION. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ANGIOGRAPHY SHOWED THAT THE ANEURYSM WAS A POSTERIOR COMMUNICATING ARTERY ANEURYSM, WITH A SIZE OF 6.2 X 4.8 X 4.1, MULTIPLE CYSTS, AND DOUBLE MICROCATHETER EMBOLIZATION. UNDER THE GUIDANCE OF THE GUIDE WIRE, THE MICROCATHETER REACHED THE PREDETERMINED POSITION, AND THE QC-6-15 SPRING COIL WAS USED FOR FORMING HOOP EMBOLISM. THE DOUBLE MICROCATHETERS WERE FILLED WITH QC-5 -10/QC-4-12/APB-3-8/APB-3-6, APB-2-6 SPRING COILS IN SEQUENCE. WHEN USING APB-1.5-4, IT WAS FOUND THAT THE SPRING COIL COULD NOT COME OUT OF THE MICROCATHETER. WHEN THE MICROCATHETER WAS WITHDRAWN, IT WAS FOUND THAT THE MARK AT THE TIP END WAS BROKEN. AFTER REPLACING IT WITH THE SAME MODEL, FILLED IN 4 SPRING COILS IN SEQUENCE TO COMPLETE THE EMBOLIZATION. IT WAS REPORTED THE CATHETER WAS CRUSHED IN THE DISTAL SECTION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586356 ↗
• 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 19583229 ↗
• MalfunctionJun 21, 2024Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE CATHETER DAMAGE WAS NOT DETERMINED. THE CATHETER WAS 6-8CM AWAY FROM THE HEAT SOURCE. THE HEAT SOURCE WAS USED ON THE CATHETER FOR 20-30 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583224 ↗
• MalfunctionJun 5, 2024Break; Leak/Splash; Physical Resistance/Sticking; Break; Leak/Splash; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STRETCHED OR PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4.1MM AND THE NECK DIAMETER WAS 2.9MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER WAS FLUSHED CONTINUOUSLY PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS INSPECTED AND TESTED PRIOR TO USE WITH NO ISSUE REPORTED.  THERE WAS RESISTANCE DURING DELIVERY OF THE AXIUM COIL IN THE DISTAL END OF THE ECHELON 10 MICROCATHETER. IT WAS NOTED THAT THE CATHETER TIP WAS FOUND TO HAVE FALLEN OFF DURING DELIVERY OF THE COIL AND LEAK WAS OBSERVED. ADDITIONALLY, THE COIL STRETCHED AND DETACHED PREMATURELY. DESPITE REPORT THAT THE CATHETER HAD RESISTANCE, THE SITE NOTED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OF THE COIL. THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER AND THE PUSHER WAS NOT BENT OR BROKEN. ALL SYSTEM PARTS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470527 ↗
• InjuryMay 24, 2024Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE MICROCATHETER BROKE DURING USE. IT WAS REPLACED WITH QUALIFIED CONSUMABLES. THIS EVENT LED TO EXTENDED DIAGNOSIS AND TREATMENT TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 19393263 ↗
• MalfunctionMay 14, 2024Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE ECHELON CATHETER WAS FOUND SEPARATED/BROKEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5.7 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PATIENT HAD A POSTERIOR CEREBRAL ARTERY ANEURYSM. AFTER THE GUIDING CATHETER AND THE INTERMEDIATE CATHETER WERE IN PLACE, WHEN THE MICROCATHETER WAS BEING SHAPED, A CRACK WAS FOUND AT THE TIP END. FOR THE SAFETY OF THE OPERATION, AN SL10 MICROCATHETER WAS REPLACED AND RESHAPED. THE MICROCATHETER WAS SAFELY IN PLACE, AND THEN THE COIL WAS FILLED, THE OPERATION ENDED SAFELY.  IT WAS REPORTED THE CATHETER SEPARATION/BREAK OCCURRED. THE SEPARATION/BREAK WAS FOUND OUT OF THE PACKAGE OR DURING PREPARATION. THE PACKAGE WAS NOT DAMAGED. THE PACKAGE DID NOT SHOW EVIDENCE OF TAMPERING. THE BROKEN LOCATION WAS ON THE DISTAL SECTION. 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 19309008 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031992, 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
• Z-1556-2022 · Jun 30, 2022 · Open, Classified
  Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only