Axium Detachable Coil System QC-2-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00847536037304), received between Jan 19, 2022 and May 14, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (12 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM OF THE C7 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY, WITH A MAX DIAMETER OF 6.8 MM AND A 4.1 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED. A TREATMENT PATHWAY WAS ESTABLISHED VIA FEMORAL ARTERY PUNCTURE. AFTER THE GUIDEWIRE ADVANCED THE MICROCATHETER INTO POSITION, AN AXIUM COIL WAS DELIVERED INTO THE MICROCATHETER AND ADVANCED INTO THE ANEURYSM. ONCE IN POSITION, THE COIL COULD NOT BE DETACHED. THE SECONDARY DETACHMENT POINT WAS MANUALLY ACTIVATED, BUT THE COIL STILL COULD NOT BE DETACHED. THE NUMBER OF ATTEMPTS MADE BY THE PHYSICIAN TO DETACH THE COIL WITH THE INSTANT DETACHER IS UNKNOWN. THE PHYSICIAN DID NOT ATTEMPT DETACHMENT USING ANOTHER INSTANT DETACHER. A MANUAL DETACHMENT ATTEMPT VIA HYPOTUBE WAS PERFORMED. THE NUMBER OF TIMES THE MANUAL DETACHMENT METHOD WAS ATTEMPTED IS UNKNOWN. THE INSTANT DETACHER WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE IT WAS LOST. NO ISSUE WITH THE INSTANT DETACHER WAS REPORTED. TO ENSURE PROCEDURAL SAFET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173304 ↗
• MalfunctionJan 6, 2026Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A HEPATIC ARTERY EMBOLIZATION PROCEDURE, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE BARE AXIUM HELIX COIL TO THE MIDDLE SECTION OF THE ECHELON MICROCATHETER, AND THE COIL DELIVERY ROD KINKED. CATHETER RESISTANCE WAS NOTED IN THE PROXIMAL SEGMENT. THE ISSUE OCCURRED WITH TWO SEPARATE COILS. IT WAS CONTRADICTORILY STATED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE PATIENT WAS TREATED FOR A HEPATIC VASCULAR EMBOLISM, WITH THE MICROCATHETER INSERTED VIA THE FEMORAL ARTERY (DIAMETER 10MM) TO REACH THE LESION SITE. THE REPORTED DEVICES AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE, AND CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. AFTER THE COIL DELIVERY ROD KINKED TWICE, BOTH COILS WERE REMOVED, AND A PRODUCT FROM ANOTHER MANUFACTURER WAS USED, WHICH WAS SUCCESSFULLY ADVANCED AND DETACHED. SUBSEQUENT COIL FILLING WAS PERFORMED, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE SURGERY WAS COMPLETED WITHOUT ANY REPORTED SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, INFECTIONS, ILLNESSES, IRREGULARITIES, OR DEATHS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976073 ↗
• MalfunctionNov 21, 2025Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE DAMAGE WAS OBSERVED DURING HYDRATION. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE DAMAGE WAS NOTICED UPON OPENING THE PACKAGE. THERE WAS NO PREPARATION PERFORMED PRIOR TO THE DAMAGE BEING SEEN; IT WAS DISCOVERED DURING THE HYDRATION PROCESS. THE DELIVERY GUIDE WIRE WAS DAMAGED; THE COIL ITSELF WAS NOT DAMAGED. KINKING OCCURRED, AND FRACTURE WAS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622027 ↗
• MalfunctionJul 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS COULD NOT BE ADVANCED OUT OF THE PROTECTIVE SHEATH. THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, UNRUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER BRAND. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613464 ↗
• MalfunctionMay 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THE RESISTANCE WAS IN THE ECHELON 10 HUB AND NOT THE COIL SHEATH. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THE ECHELON CATHETER WAS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031433 ↗
• MalfunctionApr 18, 2025Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A REBAR WAS OCCLUDED/BLOCKED AND THE GUIDEWIRE COULD NOT PASS THROUGH. ADDITIONALLY, AN AXIUM COIL STRETCHED AND HAD SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL WAS REMOVED FROM THE PATIENT BY REMOVING THE WHOLE MICROCATHETER. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE HAD BEEN FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES. THERE WAS NO ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICES 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 EMBOLIZATION FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5.3MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 20MM DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865322 ↗
• MalfunctionSep 5, 2024Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE IN THE MIDDLE SECTION OF THE ECHELON CATHETER AND THE CATHETER AND COIL WERE BOTH DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE/SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8MM. IT WAS REPORTED THAT THE MICROCATHETER WAS PLACED IN PLACE. AFTER FILLING THE FIRST COIL, THE MICROCATHETER WAS KICKED OUT OF THE ANEURYSM NECK. RESHAPED AND RE-PLACED AGAIN, AND INSERTED MULTIPLE TIMES. THE FINAL COIL WAS QC-2-8-HELIX, AND THE DELIVERY WAS FOUND TO BE STUCK. AFTER THE SPRING COIL WAS REMOVED, THE COIL BODY FELL OFF, AND THE MICROCATHETER WAS REMOVED AND FOUND TO BE KINKED IN THE PROXIMAL SECTION, AND THE MICRO GUIDE WIRE USED FOR GUIDANCE WAS STUCK. THE IMPLANT COIL WAS ALSO DAMAGED. AFTER THAT, THE MICROCATHETER WAS REPLACED AND SUCCESSFULLY ENTERED THE ANEURYSM CAVITY FOR EMBOLIZATION. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146015 ↗
• MalfunctionAug 28, 2024Break; Stretched; Break; Stretched

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO KNOWN ISSUES THAT RESULTED IN THE COIL DAMAGE/BREAK. THE COIL WAS NOT DETACHED SO IT WAS NOT IMPLANTED; IT WAS REMOVED FROM THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086922 ↗
• MalfunctionJul 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE/GOT STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM IN C5 WITH A MAX DIAMETER OF 3.8 MM AND A 1.4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT DURING ANEURYSM SURGERY, THE AXIUM SPRING COIL WAS PUSHED TO THE HUB OF THE MICROCATHETER, BUT IT DID NOT MOVE AND GOT STUCK IN THE SHEATH. REPLACED IT WITH THE SAME MODEL AND PUSHED IT SMOOTHLY. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN SHEATH. 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. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT WHEN THE SPRING COIL WAS PUSHED, THE RESISTANCE WAS AT THE PROTECTIVE SHEATH. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731650 ↗
• MalfunctionMar 14, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE COULD NOT BE DETACHED BY NORMAL OPERATION. 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 18902759 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Material Deformation; Packaging Problem; Detachment of Device or Device Component; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PUSHWIRE WAS KINKED AND THE AXIUM COIL WAS FOUND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 6.2 MM AND A 4.8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT WHEN THE QC-2-8-HELIX DETACHABLE SPRING COIL WAS JUST TAKEN OUT OF THE PACKAGE OUTSIDE THE BODY, THE DELIVERY ROD WAS FOUND TO BE KINKED. THE SURGEON TRIED TO PUSH THE SPRING COIL OUTSIDE THE BODY AND FOUND THAT THE SPRING COIL HAD DETACHED ITSELF. THE SURGEON BELIEVED THAT THIS WAS A PRODUCT QUALITY PROBLEM AND REQUIRED IT TO BE RETURNED FOR IDENTIFICATION. IT WAS REPORTED THE PUSHER WAS KINKED/BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE WAS LOCATED ON THE DISTAL SECTION OF THE PUSHWIRE. IT WAS REPORTED COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE COIL WAS NOT IMPLANTED, THE COIL SEPARATED EARLY WHEN TRYING TO PUSH OUTSIDE THE BODY. THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552531 ↗
• MalfunctionNov 9, 2023Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE ECHELON-10 MICROCATHETER WAS IN PLACE, AN AXIUM COIL WAS USED FOR THE FIRST COIL FOR EMBOLIZATION, AND THE AXIUM COIL WAS DETACHED AFTER IT SUCCESSFULLY REACHED THE POSITION. WHEN ENTERING THE AXIUM COIL, THE RESISTANCE WAS VERY HIGH. IT WAS PUSHED SEVERAL TIMES, BUT THE RESISTANCE WAS STILL VERY HIGH. AFTER THE AXIUM COIL WAS WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE DISTAL END OF THE PUSH ROD WAS KINKED AND THE PROXIMAL END WAS BROKEN AND THE SPRING COIL WAS DETACHED OUTSIDE THE BODY. THE COIL WAS REPLACED AND SUCCESSFULLY ENTERED AND DETACHED. THE OPERATION WAS SUCCESSFULLY COMPLETED. THE AXIUM AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR A GASTRIC VASCULAR BLEEDING TREATMENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE OCCURRED IN THE PROXIMAL SECTION. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. IT WAS NOTED THAT THE COIL DETACHED IN VITRO. ADDITIONAL INFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107901 ↗
• MalfunctionAug 17, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 3.5 MM AND A 2.8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SURGEON PERFORMED ANEURYSM EMBOLIZATION. AFTER THE MICROCATHETER WAS IN PLACE AND THE FIRST COIL WAS FILLED, THE QC-2-8-HELIX COIL WAS SELECTED FOR EMBOLIZATION. AFTER PUSHING IT INTO THE MICROCATHETER, THE RESISTANCE WAS RELATIVELY LARGE, AND IT WAS FOUND TO BE STRETCHED WHEN IT WAS WITHDRAWN FROM THE BODY. THEN REPLACED IT WITH A NEW QC-2-4-3D COIL FOR EMBOLIZATION, AND THE SURGERY WAS COMPLETED NORMALLY. THE OPERATOR THOUGHT IT WAS A PRODUCT QUALITY PROBLEM AND REQUESTED TO RETURN IT, PLEASE IDENTIFY IT. IT WAS REPORTED THERE WAS CATHETER RESISTANCE/STUCK IN THE MIDDLE SECTION OF THE CATHETER. THERE WAS NO CATHETER DAMAGE OBSERVED. IT IS UNKNOWN IF THERE WAS COIL DAMAGE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568677 ↗
• MalfunctionMay 23, 2023Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE MODEL AND LOT NUMBER OF THE CATHETER USED WAS UNKNOWN. THERE WERE NO ISSUES THAT RESULTED IN THE STRETCH DAMAGE THAT WAS FOUND. THERE WERE NO DETACHMENT ATTEMPTS MADE. IT WAS UNKNOWN IF THERE WAS ANY KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983320 ↗
• MalfunctionMay 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THE PUSHWIRE WAS SEPARATED IN THE DISTAL SECTION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT OR INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918680 ↗
• 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 16895130 ↗
• MalfunctionMay 5, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PUSHED OUT DIFFICULTY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, RUPTURED BASILAR ARTERY ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE FIRST COIL 2-8 WAS FILLED, AND IT WAS FOUND THAT AFTER THE COIL CAME OUT A LITTLE AT THE TIP END OF ECHELON10, IT COULDN'T BE PUSHED. SO IT WAS REPLACED WITH ANOTHER QC2-8, AND THE FILLING WAS SMOOTH. THE COIL WAS STUCK IN THE CATHETER IN THE DISTAL SECTION. THE CATHETER WAS NOT DAMAGED. IT WAS UNKNOWN IF THE COIL WAS DAMAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE MODEL AND LOT NUMBER OF THE ECHELON CATHETER WAS 145-5091-150, LOT # B375585. THERE WAS NO PROBLEM WITH THE MICROCATHETER. IT WAS USED TO FEED OTHER COILS TO THE ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876155 ↗
• MalfunctionDec 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS GREAT RESISTANCE OF BOTH COILS AND THEY WERE STUCK IN THE SHEATH AND COULDN'T COME OUT. THE REPORTED DEVICES 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 WHICH WAS UNKNOWN. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035195 ↗
• MalfunctionJan 19, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE LAST COIL USED IN THE PROCEDURE COULD NOT BE DETACHED. TWO ATTEMPTS WERE MADE WITH THE INSTANT DETACHER. ANOTHER INSTANT DETACHER WAS NOT USED, AND NO MANUAL DETACHMENT ATTEMPTS WERE MADE. THERE WERE NO PROBLEMS WITH THE INSTANT DETACHER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 3MM, AND THE NECK DIAMETER WAS 1.7MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289955 ↗

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-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
• 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