Axium Detachable Coil System QC-2-4-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00847536037625), received between Jun 13, 2022 and Jun 30, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Difficult or Delayed Positioning; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED DIFFICULT PLACEMENT. IT WAS REPORTED THAT THE 2-6 COIL WAS ADVANCED BUT COULD NOT BE PLACED IN. IT WAS REPLACED WITH A 2-4 COIL, BUT THE 2-4 COIL SILL COULD NOT BE PLACED IN. THEN A 1.5 MM PRIME COIL WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. THE DEVICES DID NOT JUMP DURING DEPLOYMENT AND THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS UNDER STRESS FOR THE 2-4 COIL, BUT NOT FOR THE 2-6 COIL, AND THE CATHETER MOVED DURING DEPLOYMENT. THE PHYSICIAN ROTATED THE 2-6 COIL DELIVERY PUSHER DURING THE PROCEDURE. THE ANEURYSM DID NOT RUPTURE. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE VESSEL TORTUOSITY WAS NORMAL. THE PATIENT EXPERIENCED NO ADVERSE REACTIONS RELATED TO THE EVENT. THE CAUSES OR CONTRIBUTING FACTORS FOR THE DIFFICULT PLACEMENT AND CATHETER MOVEMENT COULD NOT BE DETERMINED. THE USED CATHETER WAS AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25672579 ↗
• MalfunctionJun 26, 2026Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF ECHELON 10 CATHETER KICKBACK AND RESISTANCE WITH AN AXIUM COIL. THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, ANTERIOR COMMUNICATING ARTERY ANEURYSM. IT HAD A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PATIENT HAD AN ANTERIOR COMMUNICATING ARTERY ANEURYSM AND UNDERWENT STENT-ASSISTED COIL EMBOLIZATION. A DUA L-MICROCATHETER TECHNIQUE WAS USED. AFTER BOTH MICROCATHETERS WERE POSITIONED, THE COIL WAS FIRST DELIVERED THROUGH ONE ECHELON-10 MICROCATHETER. DURING COIL DELIVERY, A SEVERE KICKBACK EFFECT OCCURRED, AND THE MICROCATHETER WAS WITHDRAWN. AFTER COMPLETE DEPLOYMENT OF THE STENT, THE COIL WAS DELIVERED THROUGH THE SECOND MICROCATHETER. DURING ATTEMPTED DELIVERY OF A QC-2-4-3D COIL, THE COIL COULD NOT BE ADVANCED INTO THE MICROCATHETER. DESPITE MULTIPLE ATTEMPTS, ADVANCEMENT REMAINED UNSUCCESSFUL. THE MICROCATHETER WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641932 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. RESISTANCE WAS NOTED IN THE MIDDLE SECTION OF THE CATHETER. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. AFTER REMOVAL, A KINK WAS OBSERVED IN THE COIL. THE CATHETER USED WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996930 ↗
• MalfunctionOct 23, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369466 ↗
• MalfunctionOct 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO BARE AXIUM 3D COILS ENCOUNTERED RESISTANCE AND BECAME STUCK IN THE DISTAL END OF THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED, SACCULAR, MIDDLE CEREBRAL ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.3 MM AND A 3.5 MM NECK DIAMETER. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING EACH COIL DELIVERY, RESISTANCE OF THE SPRING COILS INCREASED IN THE DISTAL END OF THE MICROCATHETER. ATTEMPTS TO PUSH THE COIL WITH INCREASED FORCE STILL FAILED TO DELIVER THE COIL AND IT BECAME STUCK IN THE CATHETER. NO CATHETER DAMAGE WAS OBSERVED. EACH OF THE REPORTED COILS WERE WITHDRAWN AND REPLACED WITH A NEW MEDTRONIC COIL. THE ANGIOGRAPHY WAS GOOD AND SHOWED NO ABNORMALITIES, AND THE SURGERY WAS COMPLETED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. IT IS UNKNOWN WHETHER THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND THE CAUSE OF THE COIL RESISTANCE COULD NOT BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328723 ↗
• MalfunctionSep 4, 2025Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL HAD RESISTANCE IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT THE SPRING COIL HAD RESISTANCE IN THE MICROCATHETER AND COULDN'T BE PUSHED OUT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE SPRING COIL HAD A KINK AND STRETCHED SHAPE. THE MICROCATHETER WAS NOT DAMAGED. THE CATHETER WAS A MEDTRONIC CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967938 ↗
• MalfunctionJul 18, 2025Stretched; Stretched

  MEDTRONIC RECEIVED REPORT THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, THE MICRO GUIDEWIRE COULD NOT PASS THROUGH THE ECHELON 10 MICROCATHETER. THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE. DURING THE SAME PROCEDURE, AN AXIUM COIL WAS STRETCHED; THE COIL WAS ALSO REPLACED TO CONTINUE THE PROCEDURE. IT WAS NOTED THAT THE DEVICES WERE PREPARED AND CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING AND COIL EMBOLIZATION PROCEDURE VIA FEMORAL ACCESS TO TREAT AN INTERNAL CAROTID ARTERY (ICA) UNRUPTURED SACCULAR ANEURYSM. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES THAT RESULTED IN THE AXIUM COIL STRETCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539043 ↗
• MalfunctionMay 5, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE AND BECAME STRETCHED. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. THE PATIENT¿S VESSEL TORTUOSITY AND BLOOD FLOW WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. ANEURYSM DIMENSIONS: MAX DIAMETER 7*8 MM AND NECK DIAMETER 5 MM. DURING THE INTRACRANIAL ANEURYSM EMBOLIZATION, AFTER THE MICROCATHETER WAS IN PLACE, THE DETACHABLE COIL QC-2-4-3D WAS SELECTED FOR FILLING. THE COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER, AND THE MICROCATHETER AND COIL WERE WITHDRAWN. IT WAS FOUND THAT THE TAIL END OF THE COIL WAS STRETCHED, AND ANOTHER SYSTEM WAS REPLACED TO COMPLETE THE OPERATION SMOOTHLY. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE COIL RESISTANCE/STRETCH WAS NOT DETERMINED. THE COIL CAME OUT OF THE INTRO DUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963419 ↗
• MalfunctionJan 6, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE CATHETER WAS FUMIGATED FOR ABOUT 30 SECONDS. THE CATHETER WAS ABOUT 5 CM AWAY WAS THE STEAM SOURCE. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THE CAUSE OF THE CATHETER DAMAGE WAS NOT DETERMINED. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080182 ↗
• MalfunctionJan 2, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE TREATMENT OF A RUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY, A COIL-RELATED ISSUE OCCURRED WITH THE AXIUM HELIX COIL AND AXIUM 3D COIL, WHERE THE COIL BECAME STUCK IN THE SHEATH THREE TIMES. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 5 MILLIMETERS AND A NECK DIAMETER OF 2 MILLIMETERS, WITH MODERATE VESSEL TORTUOSITY AND NORMAL BLOOD FLOW. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE ISSUE INVOLVED COIL RESISTANCE AND THE COIL BEING STUCK IN THE SHEATH. THE RESOLUTION OR OUTCOME OF THE EVENT WAS NOT SPECIFIED. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL ACCIDENTALLY BROKE DURING THE PROCEDURE, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063999 ↗
• MalfunctionOct 10, 2024Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT A COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING HEPATIC TUMOR EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT WHEN PERFORMING SURGERY, THE SURGEON PREPARED THE COIL ACCORDING TO THE STANDARD PROCEDURE IN THE INSTRUCTION MANUAL. THE COIL WAS PUSHED OUT OF THE SHEATH AND FOUND TO BE STRETCHED DURING INSPECTION. IT WAS NOTED THAT COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. A NEW COIL WAS REPLACED AND THE SURGERY CONTINUED. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING THE DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ATTEMPT TO DETACH THE COIL. THE DELIVERY PUSHER WAS NOT ROTATED DURING THE PROCEDURE AND CONTINUOUS FLUSH WAS NOT ADMINISTERED. 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 20416788 ↗
• MalfunctionSep 12, 2024Stretched; Separation Failure; Material Deformation; Stretched; Separation Failure; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WERE 0 ATTEMPTS AT DETACHMENT WITH THE INSTANT DETACHER AND 2 ATTEMPTS AT MANUAL DETACHMENT. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THE PUSHROD WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207754 ↗
• MalfunctionSep 9, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED. THERE WERE 5 ATTEMPTS MADE TO DETACH THE COIL WITH THE INSTANT DETACHER (ID). IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE ID. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20172877 ↗
• MalfunctionJun 25, 2024Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY, C6 SEGMENT WITH A MAX DIAMETER OF 3MM AND A 1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PACKAGE WAS OPENED AND HYDRATED, THEN DELIVERED INTO THE MICROCATHETER. IT WAS FOUND THAT THE SPRING COIL WAS STRETCHED AND WAS WITHDRAWN FROM THE BODY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607857 ↗
• MalfunctionMay 13, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE COIL WAS PUSHED INTO THE ANEURYSM CAVITY NORMALLY WITHOUT ANY PROBLEMS. THERE WAS NO PUSHWI RE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298789 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) MADE. THERE WAS NO KINK/D AMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298391 ↗
• MalfunctionApr 3, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS WERE FOUND STRETCHED AND ANOTHER TWO AXIUM COILS WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AXIUM COIL (LOT #226008758 AND 226008758) WAS STRETCHED AND SUCCESSFULLY IMPLANTED AFTER REPLACEMENT. IT WAS REPORTED FOR THE ECHELON CATHETER THE SPRING COIL COULD NOT BE DELIVERED TO THE LESION, BUT THE OPERATION WAS SUCCESSFULLY COMPLETED AFTER REPLACEMENT. IT WAS REPORTED THAT THE AXIUM COIL (LOT # 226235035 AND 225769257) WAS DIFFICULT TO DETACH AND IMPLANTED SMOOTHLY AFTER REPLACEMENT. 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 19034011 ↗
• MalfunctionMar 20, 2024Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL HAD STRETCHED. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSION: MAX DIAMETER 5 MM AND NECK DIAMETER 2 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. AFTER THE MICROCATHETER WAS IN PLACE, A COIL WAS SELECTED FOR FILLING. IT WAS FOUND THAT THE TAIL END OF THE COIL WAS STRETCHED. THE COIL WAS REPLACED AND THE FILLING WAS SUCCESSFULLY TO COMPLETE THE SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944501 ↗
• InjuryJan 3, 2024Compatibility Problem; Physical Resistance/Sticking; Compatibility Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AT 10: 30 A.M. ON (B)(6) 2023, WHEN AN INTRACRANIAL ANEURYSM OPERATION WAS PERFORMED IN THE INTERVENTIONAL CENTER, WHEN THE SURGEON USED THE MICROCATHETER 1.0, THE MICROCATHETER LUMEN WAS BLOCKED AND THE SPRING COIL COULD NOT PASS THROUGH THE MICROCATHETER LUMEN. ANOTHER MICROCATHETER 1.0 WAS IMMEDIATELY REPLACED TO CONTINUE THE OPERATION. NO ADVERSE CONSEQUENCES WERE CAUSED TO PATIENT, AND ADVERSE EVENT WAS REPORTED IN TIME AND THE CONSUMABLE MANAGEMENT DEPARTMENT WAS INFORMED. THERE WAS EXTENDED OPERATION TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL USED IN THE PROCEDURE WAS A MEDTRONIC COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435414 ↗
• MalfunctionJul 13, 2023Display or Visual Feedback Problem; Incomplete or Missing Packaging; Display or Visual Feedback Problem; Incomplete or Missing Packaging

  MEDTRONIC RECEIVED A REPORT THAT THE QC SPRING COIL WAS PUSHED OUT BUT THERE WAS NO COIL. AFTER NORMAL HYDRATION, THE COIL WAS TRANSPORTED INTO THE PATIENT'S BODY THROUGH THE MICROCATHETER. NO COIL BODY WAS FOUND UNDER FLUOROSCOPY. AFTER BEING WITHDRAWN FROM THE BODY, IT WAS FOUND THAT IT WAS NOT THERE, NOR WAS IT IN THE MICROCATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING SEGMENT OF LEFT I NTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.1MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED THAT IT WAS CLARIFIED THAT THE CUSTOMER REPORTED THAT THERE IS NO COIL BODY AT THE TIP END OF THE COIL, AND IT WAS NOT SEEN UNDER FLUOROSCOPY, NOR WAS IT FOUND AFTER WITHDRAWING FROM THE BODY, NOR WAS IT IN THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315385 ↗
• MalfunctionMay 31, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. IT IS UNKNOWN IF THERE WAS ANY PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030100 ↗
• MalfunctionMay 9, 2023Therapy Delivered to Incorrect Body Area; Stretched; Migration; Therapy Delivered to Incorrect Body Area; Stretched; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. LATER, THE COIL WAS REPLACED AND THE FILLING WAS PREFORMED AGAIN. THE PATIENT HAS NOT AND WILL NOT RECEIVED AN MEDICAL/SURGICAL INTERVENTION AS A RESULT OF THE COIL MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895149 ↗
• MalfunctionFeb 22, 2023Stretched; Separation Failure; Stretched; Separation Failure

  NEW INFORMATION RECEIVED THAT BOTH AXIUM COILS DID NOT HAVE NON-DETACHMENT ISSUES. THE COIL(S) WERE REMOVED FROM THE PATIENT WITH TH E MICROCATHETER. THE PROCEDURE WAS COMPLETED BY SELECTING ANOTHER SPRING COIL FROM OTHER MANUFACTURER. THE INSTANT DETACHER LOT NUMBER IS UNKNOWN. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416526 ↗
• MalfunctionFeb 22, 2023Separation Failure; Separation Failure

  NEW INFORMATION WAS RECEIVED. IT IS UNKNOWN WHICH COIL HAD NON- DETACHMENT. THE ISSUE WITH THE OTHER COIL THAT DID NOT HAVE NON-DET ATTACHMENT WAS THE COIL WAS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416490 ↗
• MalfunctionJan 26, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING SURGERY, AFTER TWO SPRING COILS WERE FILLED, THE THIRD COIL WAS FILLED, AND THE TIP COULD NOT COME OUT OF THE MICROCATHETER. AFTER IT WAS WITHDRAWN, IT WAS OBSERVED THAT THE SPRING COIL WAS STRETCHED. LATER, AFTER REPLACING THE SPRING COIL, THE SURGERY COULD BE PERFORMED SMOOTHLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED LEFT SIDE OF POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE AN EV3 E-CHELON10 45° MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER WAS STUCK IN THE DISTAL END OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250271 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab
• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a