AxiumTM APB-5-10-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00847536008182), received between Jan 11, 2019 and Dec 6, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE DURING DELIVERY AND BECAUSE STRETCHED AND DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT MIDDLE CEREBRAL ARTERY (MCA) RUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6.5MM AND THE NECK DIAMETER WAS 2.4MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO PUSH THE COIL THROUGH THE MICROCATHETER. THE COIL WAS THE SECOND ONE USED IN THE PROCEDURE. DESPITE TWO ATTEMPTS TO ADVANCE THE COIL, IT BECAME STUCK IN THE MIDDLE OF THE CATHETER. DURING THE PROCESS OF REMOVING THE COIL, IT STRETCHED AND DETACHED PREMATURELY WITHIN THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE MICROCATHETER FROM THE ANEURYSM AND SUCCESSFULLY PUSHED THE DETACHED COIL OUT OF THE MICROCATHETER. IT WAS NOTED THAT THE PHYSICIAN HAD REPOSITIONED THE COIL TWICE BUT NO ATTEMPT HAD BEEN MADE TO DETACH THE COIL. THE PUSHWIRE WAS NOT BENT OR BROKEN AND THE PHYSICIAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860746 ↗
• MalfunctionNov 12, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE AXIUM COIL WAS INSERTED AND THE SHEATH WAS REMOVED, IT GOT CAUGHT ON THE WIRE, THE SHEATH COULD NOT BE REMOVED FROM THE WIRE, SO IT WAS COLLECTED. INITIALLY, 5 MM×10 MM WAS USED BUT THE SHEATH COULD NOT BE REMOVED; THE SIZE WAS CHANGED TO 5 MM×15 MM, BUT AGAIN, THE SHEATH COULD NOT BE REMOVED, SO IT WAS COLLECTED IN THE SAME MANNER. WHEN TRYING TO REMOVE THE SHEATH, PULLED HARD ENOUGH THAT IT STRETCHED, BUT IT WOULD NOT COME OUT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669683 ↗
• MalfunctionJul 9, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE LESION BEING TREATED WAS AN INTERNAL CAROTID- PC 7MM. VESSEL TORTUOSITY WAS NORMAL. THE COIL WAS REPLACED TO RESOLVE THE RESISTANCE. THE CATHETER WAS ANOTHER COMPANIES PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704525 ↗
• MalfunctionJul 1, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT COIL PUSHWIRE WAS STUCK IN THE INSTANT DETACHER. IT WAS REPORTED THAT AFTER DEPLOYING THE FIRST COIL IN THE ANEURYSM, THE DOCTOR TRIED TO DETACH THE COIL USING THE INSTANT DETACHER (ID). THE COIL DETACHED, BUT THE PUSHWIRE GOT STUCK INSIDE THE ID. DUE TO THE DAMAGE THE ID WAS UNABLE TO BE USED FOR FURTHER COILS. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646250 ↗
• MalfunctionApr 5, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THIS PRODUCT WAS USED IN THE FIRST CASE OF CEREBRAL ANEURYSM (LT. ICA-PARACLINOID), BUT IT COULD NOT BE DETACHED EVEN AFTER USING ID-1-5 (B628329), FOLLOWED BY FORCED DETACHMENT IN TWO PLACES. THE DELIVERY WIRE WAS PUSHED AND PULLED SEVERAL TIMES TO DETACH. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055132 ↗
• MalfunctionSep 15, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT WITHOUT DETACH, THE COIL WAS REMOVED. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761643 ↗
• MalfunctionJun 7, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT 2 AXIUM COILS WERE BROKEN. THE COIL WAS BROKEN; THE SIZE WAS CHANGED ON THE NEXT ONE, BUT IT WAS ALSO BROKEN. AFTER THAT, IT WAS REPLACED WITH A COIL FROM OTHER COMPANY AND WAS ABLE TO FINISH WITHOUT ANY TROUBLE. ON A SIDE NOTE, THE COIL OF THE OTHER COMPANY COULD BE PLACED PROPERLY WITHOUT GETTING BROKEN. THE COIL EXTENSION WAS BROKEN. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COILS WERE NOT REPOSITIONED. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURYSM. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14627848 ↗
• MalfunctionApr 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN EARLY DETACHMENT OCCURRED WITH THE AXIUM COIL. THE COIL BROKE INSIDE THE PATIENT'S BODY. THE COIL WAS NOT PLACED IN THE INTENDED POSITION. A CRIMPING IN THE STENT WAS USED TO FIXATE THE COIL. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THERE WAS NO DEFORMATION OR DAMAGE IN THE DELIVERY PUSHER. THERE WAS NO RESISTANCE DURING DELIVERY. THE COIL WAS REPOSITIONED 1 TIME. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL AND THE DELIVERY PUSHER WAS NOT ROTATED INSIDE THE PATIENT'S BODY. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT VA WITH A MAX DIAMETER OF 8MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE: SL-10 MICROCATHETER, LOT NUMBER: 22964064.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115717 ↗
• MalfunctionFeb 8, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DETACHED DESPITE IT BEING AN UNANTICIPATED DETACHMENT. THE COIL IMPLANT ITSELF WAS COLLECTED FOR EACH MICROCATHETER. THE COIL WAS DAMAGED/EARLY DETACHMENT. NO ADDITIONAL SURGICAL OR MEDICAL TREATMENT WAS PERFORMED. THERE WAS NO DEFORMATION OR DAMAGE TO THE DELIVERY PUSHER. THERE WAS NO RESISTANCE FELT DURING THIS DELIVERY. THE COIL WAS NOT REPOSITIONED AND THE COIL DISLODGEMENT WAS NOT ATTEMPTED. THE DELIVERY PUSHER WAS NOT ROTATED INSIDE THE PATIENT. THERE WAS A CONTINUOUS FLUSH DURING THE PROCEDURE. THE SECOND COIL WAS INSERTED FROM THE SHEATH TO THE MICROCATHETER AND RESISTANCE WAS FELT. FLUSHING WAS PERFORMED AGAIN, HOWEVER, IT DID NOT CHANGE THE RESULT THUS THE COIL WAS COLLECTED. THE COIL WAS STUCK IN THE SHEATH. THE PRODUCT WAS PREPARED AS INDICATED IN THE IFU. THERE WAS NO HEALTH DAMAGE REPORTED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 2.5MM NECK DIAM ETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13489838 ↗
• MalfunctionJan 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED EARLY IN THE MICROCATHETER. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTION IN THE PACKAGE INSERT. THE COIL WAS NOT REPOSITIONED. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE DELIVERY PUSHER DID NOT ROTATE INSIDE THE PATIENT'S BODY. CONTINUOUS FLUSH WAS ADMINISTER DURING THE PROCEDURE. NO SYMPTOMS WERE REPORTED.  ANCILLARY DEVICES: UNKNOWN SHEATH, UNKNOWN GUIDE CATHETER, SL10 MICROCATHETER, UNKNOWN GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237365 ↗
• MalfunctionJan 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM. IT WAS REPORTED THAT THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTION FOR USE (IFU). CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ATTEMPT TO DETACH THE COIL. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180916 ↗
• MalfunctionJan 12, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING A PROCEDURE FOR COIL EMBOLIZATION TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF A POSTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE AXIUM COIL WAS USED AND FAILED TO DETACH DURING THE PROCEDURE. THE PHYSICIAN ATTEMPTS 2-3 TIMES USING THE INSTANT DETACHER WITHOUT SUCCESS. THERE WAS NO ATTEMPT TO TRY A DIFFERENT INSTANT DETACHER NOR TO DETACH MANUALLY. THE COIL WAS REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155672 ↗
• MalfunctionNov 20, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THE COIL DID PUSH OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND THERE WAS NO KINK OR DAMAGE OBSERVED TO THE COIL AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10879746 ↗
• MalfunctionOct 28, 2020Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SL-10 MICROCATHETER WAS SHAPED WITH A HEAT GUN AT 130 DEGREES C FOR 30 SECONDS. THE FIRST COIL (NON-MEDTRONIC) DID NOT WORK WELL WHEN AN ATTEMPT WAS MADE TO PERFORM EMBOLIZATION. THE PRIME FRAME 8-30 COIL WAS PLACED AND DETACHED. A PRIME 5-10 COIL WAS THEN USED, AND IT WAS DETACHED WITH THE DETACHER IN THE SAME WAY. AFTER CONFIRMING THE DETACHMENT, THE COIL WAS ATTACHED FROM THE PART AWAY FROM THE DETACHED PART THOUGH THE PUSHER WIRE WAS RETRIEVED. AS A RESULT, THE COIL SEEMED TO BE STRETCHED. MANUAL DETACHMENT WAS PERFORMED AGAIN, AND THE PUSHWIRE WAS RETRIEVED. THE COIL AFTER DETACHMENT WAS TOO HARD TO BE PUSHED EVEN THOUGH IT WAS PUSHED AT THE REAR END OF THE CHIKAI. THE HUB OF THE SL-10 WAS CUT, AND THE COIL WAS SAFELY RECOVERED USING A SNARE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND 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 LEFT BASILAR ARTERY-SUPERIOR CEREBELLAR A RTERY (BA-SCA) WITH A MAX DIAMETER OF 4*9 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10750062 ↗
• MalfunctionAug 6, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE M-1 BIFURCATION WITH A MAX DIAMETER OF 20MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS DELIVERED WITH NO ISSUE, BUT THE COIL FAILED TO DETACH AT THE TARGET LOCATION. AN INSTANT DETACHER WAS USED TWICE, A SECOND INSTANT DETACHER WAS USED TWICE, AND THEN THE MANUAL DETACHMENT METHOD WAS PERFORMED ONCE. AFTER ALL OF THE ATTEMPTS, THE COIL STILL DID NOT DETACH. THE COIL WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10375963 ↗
• MalfunctionJun 26, 2020Deformation Due to Compressive Stress; Detachment of Device or Device Component; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE CATHETER. IT WAS REPORTED THAT WHEN DEPLOYING THE COIL IT BECAME STUCK IN THE MIDDLE OF THE CATHETER AND GOT BENT AFTER NOT MOVING FURTHER. WHEN THE DOCTOR TRIED TO TAKE THE COIL OUT IT SELF-DETACHED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10198408 ↗
• MalfunctionJul 17, 2019Failure to Eject; Failure to Eject

  MEDTRONIC RECEIVED A REPORT THAT, AFTER SUCCESSFULLY PLACING THE COIL, THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE INSTANT DETACHER. HOWEVER, IT WOULD NOT DETACH AFTER THE FIRST ATTEMPT SO THEY USED THE INSTANT DETACHER A FURTHER 2 TIMES UNSUCCESSFULLY. THEY THEN BROKE THE HYPOTUBE AND MANUALLY PULLED THE FILAMENT, BUT THE COIL REMAINED DETACHED TO THE PUSHER. AT THIS POINT THE PHYSICIAN ATTACHED A TORQUE PIN TO THE PUSHER AND GENTLY ROTATED THE PUSHER IN ORDER TO ACHIEVE DETACHMENT, BUT THE COIL REMAINED ATTACHED AFTER APPROXIMATELY 20 COMPLETE REVOLUTIONS. THE COIL WAS THEN ATTEMPTED TO BE REMOVED, AND AFTER ~1CM OF THE COIL WAS PULLED BACK INTO THE CATHETER IT FINALLY DETACHED. THE PHYSICIAN WAS THEN ABLE TO SUCCESSFULLY PUSH THE 1CM OF COIL BACK INTO THE ANEURYSM WITH A GUIDEWIRE. THE CASE WAS COMPLETED WITH 4 FURTHER COILS IMPLANTED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT A RUPTURED, SACCULAR, BASILAR TIP ANEURYSM WITH A MAX DIAMETER OF 5MM AND A NECK DIAMETER OF 3MM. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. ANCILLARY DEVICES INCLUDE A STRYKER SL10 MICROCATHETER AND SYNCHRO GU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8801144 ↗
• MalfunctionJan 11, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT FOR A INTERNAL CAROTID ARTERY ANEURYSM, THIS COIL WOULD NOT DETACH WITH AN INSTANT DETACHER OR USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE), BUT DETACHED AFTER SEVERAL ATTEMPTS. IT WAS A RECANALIZATION CASE DUE TO COMPACTION FOR AN UNRUPTURED CEREBRAL ANEURYSM WHICH WAS A LITTLE DOWNWARD LOCATING ON THE BIFUR CATION OF THE ORIGIN OF THE RIGHT PCA FROM BA-TOP. THE SIZE OF THE ANEURYSM WAS 11.5 MM IN LENGTH AND 8.5 MM IN WIDTH. THE NECK WAS 7.9 MM. THE VESSEL WAS MODERATELY TORTUOUS. PREVIOUSLY, A CRANIOTOMY CLIP PROCEDURE NEAR THE NECK (ORIGIN OF THE RIGHT PCA) OF THE SAME ANEURYSM HAD BEEN PERFORMED AND THE CLIP(S) HAD EXISTED THERE. IN ADDITION, COIL EMBOLIZATION HAD ALSO BEEN PERFORMED INSIDE THE ANEURYSM AND THERE WAS A SMALL AMOUNT OF COIL REMAINING IN THE ANEURYSM WALL. THE PHYSICIAN PUNCTURED FROM THE RIGHT FEMORAL AND PLACED 7F ROADMASTER IN THE ORIGIN OF VA. THEN, DELIVERED SL 10 FOR STENT PLACEMENT TO THE RIGHT PCA, AND HELD ANOTHER SL 10 TO PLACE INSIDE THE ANEURYSM. THE PHYSICIAN DEPLOYED ATLAS 3 × 21 FROM THE PREVIOUS SL 10 WHICH WAS SENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8241506 ↗

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