MarathonTM 105-5056Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 00847536005914), received between Mar 27, 2017 and Sep 24, 2026 — classified as 27 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (44 reports).

2 other recalls cover devices cleared under the same FDA submission (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 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889746 ↗
• MalfunctionMar 9, 2026Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE MARATHON WAS RUPTURED IN THE PROXIMAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR EMBOLIZATION OF DURAL AV FISTULA TENTORIUM MENINGITIS OCCIPITALIS. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE ANTERIOR FEMORALIS. IT WAS REPORTED THAT DURING INJECTION OF SQUID, THE PROXIMAL PART OF MARATHON BROKE AND THE LIQUID EMBOLIC FLEW IN THE GUIDING CATHETER. THE CATHETER WAS RUPTURED (INTACT) IN THE PROXIMAL SECTION. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. ASIDE FROM RUPTURE, THERE WAS NO OTHER DAMAGE TO THE CATHETER. HEALTHCARE PROVIDER (HCP) TRIED TO SAVE THE SQUID FROM THE GUIDING CATHETER, SO HCP AVOID TO BLOCK (CLOSE) THE ACCESS VESSEL. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE AN ENVOY 7 FR GUIDE CATHETER, MARATHON MICROCATHETER, SQUID 12 LIQUID EMBOLIC, SCEPTER MINI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545962 ↗
• MalfunctionFeb 20, 2026Break; Leak/Splash; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS A MARATHON LEAK AND DAMAGE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF INTRA-ARTERIAL CHEMO. THE ACCESS VESSEL WAS THE OPHTHALMIC ARTERY WITH A DIAMETER OF 3MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PATIENT IS ALIVE WITH NO INJURY. IT WAS REPORTED THAT DURING THE PROCEDURE, MARATHON BATCH D063934DB2 WAS A PROBLEM. AT THE TIME OF INJECTING THE CONTRAST AND PERFORMING THE PASSAGE OF THE MICROGUIDE, IT WAS EVIDENT THAT THE CONTRAST WAS COMING OUT OF THE SIDE OF THE DEVICE, OBSERVING THAT THE MICROCATHETER WAS DAMAGED BROKEN. FACED WITH THIS SITUATION, THE DOCTOR PROCEEDED TO RETURN THE MICROCATHETER AND REQUESTED A NEW ONE. THE SECOND MICROCATHETER DELIVERED WAS USED WITHOUT PROBLEMS AND WORKED CORRECTLY DURING THE PROCEDURE. THERE WAS A CATHETER LEAK IN THE PROXIMAL SECTION. THE CATHETER WAS INSPECTED/TESTED PRIOR TO USE. THE LEAK WAS OBSERVED DURING USE OF THE CATHETER. THE CATHETER WAS CRUSHED. IT WAS INDICATED THAT THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF FUNCTION. THE EVENT LED TO OR EXT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405661 ↗
• MalfunctionFeb 5, 2026Burst Container or Vessel; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A MARATHON MICROCATHETER THAT RUPTURED. IT WAS REPORTED THAT THE CATHETER WAS BEING USED NORMALLY DURING ANGIOGRAPHY PRIOR TO A VASCULAR MALFORMATION EMBOLIZATION. DURING INJECTION OF CONTRAST MEDIUM, THE CATHETER RUPTURED. THERE WAS NO KNOWN PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268211 ↗
• MalfunctionJan 21, 2026Break; Retraction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE PROCEDURE WAS COMPLETED WITH SUCCESSFUL TREATMENT OF THE DAVF. THERE WERE NO PLANS TO RETRIEVE THE CATHETER TIP. THE TIP WAS LOCATED AT THE MIDDLE MENINGEAL ARTERY (MMA) WITH THE PROXIMAL END IN THE INTERNAL MAXILLARY ARTERY (IMAX). THE CATHETER BREAK OCCURRED DURING RETRIEVAL. IT WAS NOTED THAT THERE HAD BEEN RESISTANCE UPON RETRIEVAL. THERE WAS NO VESSEL CALCIFICATION, AND NO KINK/DAMAGE WAS NOTED ON ANY OF THE DEVICES.

  Patient problems: Foreign Body In Patient

  MAUDE report 24132586 ↗
• MalfunctionJan 20, 2026Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE MARATHON CATHETER RUPTURED WITH ONYX. THE PATIENT WAS UNDERGOING MIDDLE MENINGEAL ARTERY EMBOLIZATION SURGERY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 2 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE OPERATOR PERFORMED MIDDLE MENINGEAL ARTERY EMBOLIZATION. A SUPPORT CATHETER WAS SELECTED AND POSITIONED AT THE INTRACRANIAL ANTERIOR CEREBRAL BIFURCATION, A MICRO GUIDEWIRE WAS USED, AND A MARATHON FLOW-DIRECTED MICROCATHETER WAS POSITIONED. ONYX 18 LIQUID EMBOLIZATION SYSTEM WAS THEN INJECTED. DURING SLOW INJECTION, ONYX GLUE WAS OBSERVED ON THE MARATHON CATHETER BODY. THE OPERATOR IMMEDIATELY REMOVED THE CATHETER AND FOUND THAT THE MARATHON CATHETER BODY WAS RUPTURED (INTACT) AT THE DISTAL END. THE OPERATOR REPORTED THAT THE INJECTION SPEED WAS STANDARD. THE INJECTION RATE WAS 0.25 ML/MIN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. ASIDE FROM RUPTURE, THERE WAS NO OTHER DAMAGE TO THE CATHETER. 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 FLU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126469 ↗
• MalfunctionJan 14, 2026Retraction Problem; Compatibility Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS PREPARED AS INDICATED IN THE IFU (INSPECTION, HYDRATION, ETC.). THE PROCEDURE WAS COMPLETED WITH ANOTHER MICRO. IT WAS NOTED THAT THE CAUSE OF THE CATHETER RESISTANCE/OCCLUSION WAS THAT THE MICRO MARATHON HAS AN OD BETWEEN 0.013 AND 0.015 SO A GUIDEWIRE LIKE TRAXESS WHICH IS 0.014 CAN BE STUCK. THE GUIDEWIRE WAS NOT ABLE TO PASS THE CATHETER HUB. THERE WAS NO DAMAGE FOUND TO THE MARATHON CATHETER. IT WAS UNKNOWN IF THE GUIDEWIRE TIP WAS SHAPED OR IF THERE WAS ANY DAMAGE TO THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068920 ↗
• MalfunctionDec 26, 2025Loss of or Failure to Bond; Retraction Problem; Patient-Device Incompatibility; Physical Resistance/Sticking; Loss of or Failure to Bond; Retraction Problem; Patient-Device Incompatibility; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT HYDROPHILIC COATING DEFECT OCCURRED INSIDE THE MARATHON CATHETER, TRAXESS WIRE COULD NOT BE REMOVED. IT WAS REPORTED THERE WAS CATHETER RESISTANCE IN THE MIDDLE OF 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A TRAXCESS GUIDEWIRE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE HYDROPHILIC COATING DEFECT WAS NOTED TO BE CATHETER RESISTANCE. THE PROCEDURE WAS COMPLETED BY CHANGING THE MICROCATHETER AND WIRE. THE CAUSE OF THE CAUSE OF THE RESISTANCE/COATING ISSUE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898320 ↗
• MalfunctionDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR ARTERIOVENOUS MALFORMATION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 6.6MM DIAMETER. IT WAS REPORTED THAT DURING THE SURGERY, WHILE SHAPING THE TIP OF THE MARATHON CATHETER WITH A SHAPING NEEDLE, IT WAS FOUND THAT THE MARK TIP HAD DETACHED. A NEW MARATHON CATHETER WAS THEN USED TO CONTINUE THE PROCEDURE. 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 23803950 ↗
• MalfunctionNov 18, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT DURING THE AVM EMBOLIZATION PROCEDURE, THE 105-5056 MICROCATHETER SUCCESSFULLY REACHED THE LESION SITE UNDER THE GUIDANCE OF THE GUIDEWIRE, AND DMSO AND ONYX WERE INJECTED SEQUENTIALLY THROUGH THE CATHETER WITHOUT ANY ABNORMALITIES. AFTER THE EMBOLIZATION WAS COMPLETED, THE DISTAL END OF THE MICROCATHETER WAS BROKEN DURING THE WITHDRAWAL OF THE MICROCATHETER FROM THE BODY. THE OPERATOR RETURNED THE REMOVED CATHETER. NO RELATED COMPLICATIONS HAD BEEN OBSERVED IN THE PATIENT SO FAR. CATHETER SEPARATION DUE TO ONYX ENTRAPMENT WAS REPORTED. THE PHYSICIAN PAUSED FOR 30 SECONDS DURING INJECTION. INJECTION WAITING TIME WAS 30 SECONDS. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. 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 ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ESSEL WAS THE RIGHT FEMORAL ARTERY WITH AN 8MM DIAMETER. ANCILLARY DEVICES INCLUDE AN ONYX LIQUID EMBOLIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586767 ↗
• MalfunctionNov 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE STUCK WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544017 ↗
• MalfunctionOct 30, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHILE PUSHING THE MARATHON TO GO UPPER, THE OPERATOR FOUND THAT THE RESISTANCE WAS TOO GREAT AND COULD NOT PUSH IT INTO PLACE. AFTER REPEATED ATTEMPTS, THE OPERATOR WITHDREW THE FLOATING MICROCATHETER AND FILED A PRODUCT COMPLAINT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. 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 IS ALIVE WITH NO INJURY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 2MM. ADDITIONAL INFORMATION WAS RECEIVED. LESION CHARACTERISTICS WERE UNKNOWN. AFTER THE EXTERNAL SUPPORT PATHWAY WAS ESTABLISHED, THE GU IDEWIRE GUIDED THE MARATHON. REPEATED ATTEMPTS FAILED TO ADVANCE IT FURTHER, BUT AFTER REPLACING IT WITH ANOTHER MARATHON, THE DEVICE COULD BE ADVANCED SMOOTHLY. THE CAUSE OF THE RESISTANCE AND DIFFICULT NAVIGATION WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427551 ↗
• MalfunctionOct 27, 2025Break; Burst Container or Vessel; Device Dislodged or Dislocated; Break; Burst Container or Vessel; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE MARATHON CATHETER WAS IN PLACE, IT WAS FOUND THAT THERE WAS NO DEVELOPMENT MARK POINT AT THE TIP. IT WAS NOTED THAT THE CATHETER WAS BROKEN/RUPTURED AT THE DISTAL LOCATION. A NEW MARATHON CATHETER WAS USED TO COMPLETE THE PROCEDURE. POSTOPERATIVE IN VITRO COMPARISONS REVEALED THAT THE MARATHON WITHOUT THE DEVELOPMENT MARK POINT WAS SHORTER THAN THE NORMAL ONE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING MIDDLE MENINGEAL ARTERY EMBOLISM SURGERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. RIGHT FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 7 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY AND NO OTHER DAMAGE TO THE CATHETER ASIDE FROM RUPTURE. THE INJECTION RATE WAS NOTED AS 1. ANCILLARY DEVICES INCLUDED ONYX LIQUID EMBOLIC. ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER TIP, INCLUDING MARKER BAND, HAD BROKEN OFF AND WERE NOT PRESENT. THERE WAS NO DAMAGE OBSERVED DURING CATHETER PREPARATION PRIOR TO USE IN THE PATIENT. OBSERVAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391269 ↗
• MalfunctionOct 3, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS UNDERGOING THE PROCEDURE FOR TREATMENT OF A DURAL ARTERIOVENOUS FISTULA (DAVF) IN THE VEIN OF GALEN (COGNARD TYPE 3), LOCATED IN THE TORCULAR REGION AND WHICH HAD INVOLVEMENT OF THE LEFT POSTERIOR CEREBRAL ARTERY (PCA). THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MARATHON SEPARATION OCCURRED DURING RETRIEVAL FROM THE GLUE CAST. A SOLITAIRE STENT WAS DEPLOYED IN THE PATIENT'S LEFT VERTEBRAL ARTERY. THE STENT ACHIEVED GOOD DEPLOYMENT AND ANCHORING OF THE SEPARATED CATHETER DISTAL SEGMENT. THE PATIENT AWOKE FROM ANESTHESIA WITHOUT FOCAL DEFICITS AND SUBSEQUENT IMAGING DID NOT SHOW ANY ACUTE COMPLICATIONS. THERE WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23206881 ↗
• MalfunctionSep 19, 2025Break; Burst Container or Vessel; Break; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE MARATHON CATHETER DISTAL END BROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING ARTERIOVENOUS MALFORMATION EMBOLIZATION WITH ONYX, A FRACTURE OCCURRED APPROXIMATELY 25 CM FROM THE DISTAL END OF THE MICROCATHETER, LEAVING THE DISTAL SEGMENT INSIDE THE PATIENT¿S BODY WHEN THE CATHETER WAS WITHDRAWN AT THE END OF THE EMBOLIZATION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED INTHE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE ONYX.

  Patient problems: Foreign Body In Patient; Ischemia; Muscle Weakness/Atrophy; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099839 ↗
• MalfunctionAug 25, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. THE DEAD SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO, AND THERE WAS NO FRICTION OR DIFFICULTY DURING FLUSHING OR INJECTION. HOWEVER, A KINK WAS OBSERVED ON THE CATHETER. ONYX REFLUX DID OCCUR, THOUGH THE EXACT AMOUNT OF REFLUX WAS UNKNOWN. THE PHYSICIAN PAUSED DURING THE INJECTION, WITH A WAITING TIME OF ONE MINUTE BETWEEN INJECTIONS. THE INJECTION RATE WAS FOLLOWED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891788 ↗
• MalfunctionAug 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A MARATHON MICROCATHETER THAT HAD RESISTANCE WITH THE GUIDEWIRE AT THE HUB. THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE VIA FEMORAL ACCESS TO TREAT A RIGHT OPHTHALMIC ARTERY VESSEL MALFORMATION INVOLVING TWO VESSELS. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AN APOLLO CATHETER WAS USED TO EMBOLIZE THE FIRST INVOLVED VESSEL. A MARATHON CATHETER WAS THEN SELECTED FOR EMBOLIZATION OF THE SECOND VESSEL. DURING THE GUIDEWIRE PLACEMENT PROCESS, THE GUIDEWIRE COULD NOT ENTER THE MARATHON CATHETER LUMEN. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE MARATHON WAS WITHDRAWN AND IT WAS FOUND THAT THE CONNECTIVE VALVE WAS LOOSE FROM THE CATHETER, RESULTING IN DISTANCE BETWEEN THE INTRODUCER SHEATH AND MARATHON CONNECTION CAUSING THE GUIDEWIRE TO BE UNABLE TO ENTER THE CATHETER LUMEN. IT WAS NOTED THAT THE POSTERIOR OPHTHALMIC ARTERY DEVELOPED SPASM AND STENOSIS SO THE PROCEDURE HAD TO BE TERMINATED THOUGH IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE DEVICE ISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED

  Patient problems: Stenosis; Vasoconstriction

  MAUDE report 22822396 ↗
• MalfunctionAug 7, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN ATTEMPTING TO PASS THE MARATHON MICROCATHETER THROUGH THE HUB, THE TIP WAS DIFFICULT TO INSERT, AND AFTER INSERTION, THERE WAS RESISTANCE DURING DELIVERY INSIDE THE CATHETER, SO IT WAS COLLECTED. UPON CHECKING AFTER REMOVAL, THE TIP WAS BROKEN AND CRUSHED AT THE SHAFT PROXIMAL, SO IT WAS REPLACED WITH A CATHETER FROM ANOTHER COMPANY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741659 ↗
• MalfunctionAug 4, 2025Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE LEAK WAS UNDETERMINED. THE PROCEDURE WAS COMPLETED WITH A SONIC CATHETER. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700353 ↗
• MalfunctionJul 28, 2025Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR EMBOLIZATION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY AND THE ACCESS VESSEL WERE UNKNOWN.  IT WAS REPORTED THAT THE MARATHON CATHETER WAS OPENED AND, WHEN PREPARED, SHOWED LEAKAGE; THEREFORE, THE ITEM WAS NOT USED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION, AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639362 ↗
• MalfunctionJul 25, 2025Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT BASAL GANGLION ARTERIOVENOUS MALFORMATION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY, WITH 7.9 MM DIAMETER.  IT WAS REPORTED THAT THE SURGEON USED ONYX GLUE INJECTION TO TREAT THE ARTERIOVENOUS MALFORMATION. AFTER THE MARATHON CATHETER WAS IN PLACE, THE SURGEON FOUND THAT THE DISTAL SECTION OF THE CATHETER WAS LEAKING GLUE DURING THE GLUE INJECTION PROCESS. THE SURGEON THEN REMOVED THE MICROCATHETER, REPLACED IT WITH A NEW ONE, AND THEN CONTINUED TO INJECT GLUE TO COMPLETE THE SURGERY. 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 22610692 ↗
• MalfunctionJul 23, 2025Break; Burst Container or Vessel; Break; Burst Container or Vessel

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE BREAK WAS NOT DETERMINED. THE MARATHON WAS BROKEN BEFORE THE INJECTION OF LIQUID EMBOLIC AGENT BEGAN, AND IT BROKE WHEN THE CONTRAST AGENT WAS INJECTED WITH A SYRINGE DURING MARATHON ANGIOGRAPHY. THERE WAS¿CONTINUOUS INJECTION OF THE LIQUID EMBOLIC AGENT. THE INJECTION RATE WAS FOLLOWED AS INDICATED IN THE COMPETITOR¿S IFU. THE LIQUID EMBOLIC AGENT DID NOT GET EMBEDDED IN AN UNINTENDED LOCATION, IT WAS INJECTED. THIS EVENT DID NOT REQUIRE¿MEDICAL INTERVENTION. THE SUBJECT IS RECOVERING WELL FROM THE PROCEDURE. IT WAS CONFIRMED THAT THERE WERE NO ISSUES WITH THE ONYX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575895 ↗
• InjuryJul 21, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE TIP BREAKAGE WAS A DEVICE ISSUE. THE PATIENT IS RECOVERING WELL. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE DISTAL TIP OF THE CATHETER BROKE. THE PORTION WAS REMOVED BY OPERATION FROM THE PATIENT. THERE WAS NO RESISTANCE OR UNUSUAL BEHAVIOR NOTED DURING DEVICE MANIPULATION PRIOR TO THE BREAK. THE BREAK WAS IDENTIFIED DURING ADVANCEMENT OR WITHDRAWAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22559419 ↗
• MalfunctionJul 14, 2025Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION FOR USE OF THE MARATHON 165 ARTERIOVENOUS MALFORMATION CATHETER WITH LIQUID EMBOLIC (SQUID), A HOLE OR BREAK ALONG THE CATHETER WERE IDENTIFIED. THERE WAS A CATHETER LEAK OBSERVED DURING PREPARATION. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPARED AS PER IFU. NO PATIENT WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493802 ↗
• MalfunctionJun 19, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292269 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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