Concerto Detachable Coil System NV-2-4-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00847536044869), received between Oct 20, 2022 and Apr 3, 2026 — classified as 2 deaths, 44 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (27 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL COULD NOT ADVANCE. ALL DEVICES WERE PREPPED AS INDICATED IN THE IFU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782653 ↗
• MalfunctionApr 3, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL COULD NOT ADVANCE. ALL DEVICES AND ACCESSORIES WERE PREPARED AS INDICATED BY THE IFU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780615 ↗
• MalfunctionFeb 12, 2026Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. A TOTAL OF 4 COILS WITH THE SAME BATCH NUMBER WERE INVOLVED WITH THE MALFUNCTION ALLEGATION. THE PROCEDURE WAS COMPLETED BY USING OTHER SIZES OF THE CONCERTO COILS. THE COILS CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. THIS INFORMATION HAS BEEN CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324269 ↗
• MalfunctionFeb 12, 2026Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. A TOTAL OF 4 COILS WITH THE SAME BATCH NUMBER WERE INVOLVED WITH THE MALFUNCTION ALLEGATION. THE PROCEDURE WAS COMPLETED BY USING OTHER SIZES OF THE CONCERTO COILS. THE COILS CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. THIS INFORMATION HAS BEEN CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324205 ↗
• MalfunctionJan 16, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL ENCOUNTERED RESISTANCE IN THE SHEATH. THE PATIENT WAS UNDERGOING TREATMENT ON THE AORTA-PULMONARY COLLATERALS. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE COIL ENCOUNTERED RESISTANCE WHEN BEING TRANSFERRED FROM THE SHEATH TO THE MICROCATHETER. IT WAS PLACED BACK INTO THE SHEATH AND THE MICROCATHETER WAS CHANGED. AN ATTEMPT WAS MADE TO TRANSFER IT TO THE MICROCATHETER TO RELEASE IT, BUT IT DID NOT NAVIGATE. IT ALWAYS PRESENTED RESISTANCE AND THE MEDICAL DEVICE COULD NOT BE IMPLANTED. THE CATHETER AND MICROCATHETER WERE REMOVED ALONG WITH THE COIL, AND A REPORT WAS COMPLETED. IT WAS REPORTED THE COIL WAS STUCK IN THE PROXIMAL SECTION OF THE CATHETER. THE IMPLANT DID NOT PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THERE WAS NO CATHETER OR COIL DAMAGE OBSERVED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099419 ↗
• MalfunctionJan 15, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS WERE STUCK IN THE CATHETER AND ENCOUNTERED RESISTANCE IN THE SHEATH. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PRODUCTS BECAME STUCK INSIDE THE CATHETER AND THE COILS DID NOT ADVANCE. THEY WERE REPLACED WITH NEW ONES, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL REPORTEDLY BECAME LODGED INSIDE THE CATHETER AND WAS REMOVED WITH DIFFICULTY. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER WAS NOT A MEDTRONIC DEVICE. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COILS WERE PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082443 ↗
• MalfunctionJan 13, 2026Separation Failure; Insufficient Device Problem Information

  MEDTRONIC RECEIVED REPORT THAT A CONCERTO COIL WOULD NOT DEPLOY. NO OTHER INFORMATION REGARDING THE EVENT OR THE PATIENT WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054315 ↗
• MalfunctionNov 13, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL WAS FOUND TO HAVE KINK DAMAGE DURING THE PROCEDURE. THE PRODUCT WAS REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547036 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. NO DETACHMENT ATTEMPTS HAD BEEN MADE. THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393149 ↗
• MalfunctionOct 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICES WERE INSPECTED WITH ISSUES NOTED AND PREPPED WITH ISSUES IDENTIFIED. THE COILS WOULD NOT COME OUT OF ITS SHIRT, EVEN IF LUBRICATED. IT WAS LUBRICATED BUT WAS STILL STUCK IN THE SHIRT. THE COIL GOT STUCK IN THE JACKET AND DID NOT ALLOW ITSELF TO BE MANIPULATED, NEITHER TO RETREAT NOR ADVANCE EVEN IF LUBRICATED. JAMMING OCCURRED DURING PREP. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT. THE LESION/VESSEL SITE OR LOCATION ASSOCIATED WITH THE EVENT WAS THE PEDAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329743 ↗
• MalfunctionOct 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CONCERTO COIL EXPERIENCED PREMATURE DETACHMENT. IT IS UNKNOWN WHETHER THE PUSHWIRE WAS BENT OR BROKEN, IF THERE WAS ANY FRICTION OR DIFFICULTY DURING DELIVERY, WHETHER THE PHYSICIAN REPOSITIONED THE COIL, ATTEMPTED TO DETACH THE COIL, OR ROTATED THE DELIVERY PUSHER DURING THE PROCEDURE.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 23235793 ↗
• MalfunctionSep 5, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE SMALL END OF THE BLACK LINE ON THE BACK OF THE CONCERTO HELIX COIL WAS PULLED TO DEPLOY IT, NOTHING CAME BACK, INCLUDING NO STRING. A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED, AND THERE WAS NO ALLEGED PRODUCT ISSUE. IT WAS NOTED THAT THE CATHETER WAS FLUSHED AND IT WAS NOT KINKED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A CONDITION OF THE ABDOMINAL ARTERIES. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL (LITTLE), DEGREE OF CALCIFICATION WAS NONE, AND THERE WAS NO STENOSIS. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. THE REPORTED DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE: 2.4 PROGREAT MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986883 ↗
• MalfunctionAug 28, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO NV-2-4-HELIX COIL WOULD NOT PASS THROUGH THE CATHETER. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS BEING USED IN ACCORDANCE WITH THE IFU BUT THE COIL DID NOT PASS THROUGH THE MICROCATHETER THAT WAS USED IN THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER RESISTANCE WAS AT THE HUB. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL OR THE CATHETER AFTER REMOVAL. THE CATHETER WAS NO A MEDTRONIC DEVICE AND MODEL INFORMATION WAS NOT PROVIDED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914141 ↗
• MalfunctionMar 18, 2025Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CONCERTO HELIX 2MM X 4CM COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER. ADDITIONALLY, THERE WERE ISSUES WITH THE PUSHER BEING KINKED OR BROKEN, AND THE COIL EXPERIENCED SEPARATION, BREAKAGE, OR PREMATURE DETACHMENT. THE COIL WAS SUBSEQUENTLY REMOVED FROM THE PATIENT THROUGH NORMAL REMOVAL FROM THE CATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633282 ↗
• MalfunctionNov 26, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE CONCERTO COILS FAILED TO DEPLOY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COILS WERE REPLACED, AND THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779230 ↗
• MalfunctionSep 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE ADVANCED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192926 ↗
• MalfunctionJul 16, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THEY FINISHED THE PROCEDURE AFTER THREE EVENT. THE BLEED HAD OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755999 ↗
• MalfunctionJun 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WOULD NOT BE ADVANCED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520362 ↗
• MalfunctionMay 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT BROKE OFF AT AN UNWANTED LOCATION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358862 ↗
• MalfunctionMay 10, 2024Separation Failure; Material Deformation; Physical Resistance/Sticking; Separation Failure; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL ENCOUNTERED RESISTANCE IN THE MICROCATHETER DISTAL TIP AND COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF GI VARICES IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE COIL CAME OUT OF MICROCATHETER, BUT THE END OF COIL GOT STUCK IN THE MICROCATHETER TIP. THE COIL WOULD NOT DETACH EVEN WHEN THE HBI WAS BROKEN. REMOVED CATHETER AND COIL, AND THE ACCOUNT STATED IT WAS VERY HARD TO PULL THE COIL OFF OF THE MICROCATHETER TIP. GEL FOAM WAS USED PRIOR TO THE COIL BEING INSERTED, BUT PHYSICIAN SAYS THE MICROCATHETER WAS MOVING EASILY AND DIDN'T FEEL THE GEL FOAM RESULTED IN THE ISSUE. IT WAS NOTED THAT THE END OF COIL RESEMBLED A BENTSON WIRE IF YOU TOOK THE TIP OFF. THE PHYSICIAN ATTEMPTED TO DETACH WITH THE INSTANT DETACHER 3 TIMES AND DID NOT TRY WITH ANOTHER DETACHER. THERE WAS ONE ATTEMPT AT MANUAL DETACHMENT. 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. ANCILLARY DEVICES INCLUDE A MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285786 ↗
• MalfunctionMay 6, 2024Stretched; Separation Failure; Physical Resistance/Sticking; Stretched; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A HEMORRHAGE. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PHYSICIAN HAS SUCCESSFULLY DELIVERED THE NV-2-4-HELIX VIA THE MERIT MAESTRO 2.4F MICROCATHETER. HOWEVER, WHEN THE PHYSICIAN TRIED TO DEPLOY THE COIL WITH INSTANT DETACHER, THE COIL IS FAILED TO DEPLOY. THEN THE COIL WAS FOUND STRETCHED AND ELONGATED. THE PHYSICIAN HAS SUCCESSFULLY RETRIEVED THE COIL. THE PHYSICIAN HAS COMPLETED THE PROCEDURE BY USING COOK NESTER PUSHABLE COILS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE NOT PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A MERIT MAESTRO 2.4 F MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250408 ↗
• MalfunctionApr 29, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DETACHER FAILED TO FUNCTION DURING PROCEDURE. COMPLETED THE PROCEDURE USING A NEW PRODUCT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202959 ↗
• MalfunctionMar 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COILS BECAME STUCK IN THE CATHETER. HEALTHCARE PROVIDER (HCP) USED PROGREAT LAMBDA 1.9. INNER D IAMETER IS 0.017", MEDTRONIC REQUIRES 0.0165". THE COIL ISSUES WERE EXPERIENCED ON (B)(6) 2023, (B)(6) 2023, AND (B)(6) 2023; HOWEVER IT WAS NOT SPECIFIED WHICH COILS WERE USED AT EACH SPECIFIC PROCEDURE AS IT WAS REPORTED AS A SINGLE EVENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905600 ↗
• MalfunctionMar 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COILS BECAME STUCK IN THE CATHETER. HEALTHCARE PROVIDER (HCP) USED PROGREAT LAMBDA 1.9. INNER DIAMETER IS 0.017", MEDTRONIC REQUIRES 0.0165". THE COIL ISSUES WERE EXPERIENCED ON (B)(6) 2023, (B)(6) 2023, AND (B)(6) 2023; HOWEVER IT WAS NOT SPECIFIED WHICH COILS WERE USED AT EACH SPECIFIC PROCEDURE AS IT WAS REPORTED AS A SINGLE EVENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905338 ↗
• MalfunctionMar 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COILS BECAME STUCK IN THE CATHETER. HEALTHCARE PROVIDER (HCP) USED PROGREAT LAMBDA 1.9. INNER D IAMETER IS 0.017", MEDTRONIC REQUIRES 0.0165". THE COIL ISSUES WERE EXPERIENCED ON (B)(6) 2023 , ON (B)(6) 2023 , AND ON (B)(6) 2023 ; HOWEVER IT WAS NOT SPECIFIED WHICH COILS WERE USED AT EACH SPECIFIC PROCEDURE AS IT WAS REPORTED AS A SINGLE EVENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905316 ↗

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