Concerto Detachable Coil System NV-2-6-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00847536044876), received between Mar 18, 2022 and Sep 1, 2026 — classified as 4 deaths, 4 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (41 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542699 ↗
• MalfunctionJul 20, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882860 ↗
• MalfunctionMay 29, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS STUCK IN THE CATHETER AND WAS UNABLE TO ADVANCE. THE DEVICE WAS STUCK IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS NOT DAMAGED. THE COIL WAS NOT DAMAGED. 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 PATIENT WAS UNDERGOING SURGERY FOR TREATMENT FOR BLEEDS. ANCILLARY DEVICES INCLUDE A BOSTON SCIENTIFIC TRUSELECT MICROCATHETER. (B)(6) 2026 E1 (REP, HCP, FOR): ADDITIONAL INFORMATION RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER CONCERTO COIL WITH NO ISSUES. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS CONTINUOUSLY FLUSHED THROUGHOUT THE PROCEDURE. A TOTAL OF FOUR COILS ENCOUNTERED RESISTANCE, ONE NV-3-8-HELIX COIL AND THREE NV-2-6-HELIX COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338114 ↗
• MalfunctionMay 29, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS STUCK IN THE CATHETER AND WAS UNABLE TO ADVANCE. THE DEVICE WAS STUCK IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS NOT DAMAGED. THE COIL WAS NOT DAMAGED. 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 PATIENT WAS UNDERGOING SURGERY FOR TREATMENT FOR BLEEDS. ANCILLARY DEVICES INCLUDE A BOSTON SCIENTIFIC TRUSELECT MICROCATHETER. ADDITIONAL INFORMATION RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER CONCERTO COIL WITH NO ISSUES. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS CONTINUOUSLY FLUSHED THROUGHOUT THE PROCEDURE. A TOTAL OF FOUR COILS ENCOUNTERED RESISTANCE, ONE NV-3-8-HELIX COIL AND THREE NV-2-6-HELIX COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338092 ↗
• MalfunctionApr 30, 2026Inadequacy of Device Shape and/or Size; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT CONCERTO COILS WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY OF A RENAL BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT UPON ACCESS OF THE RENAL VESSEL THE PHYSICIAN ATTEMPTED TO DEPLOY THE CONCERTO COIL AND WAS UNSUCCESSFUL X 3. THE STAFF REPORTED THAT THE COIL WOULD SUCCESSFULLY EXIT THE CATHETER BUT WOULD NOT TAKE SHAPE. THREE SIZES WERE ATTEMPTED AND FAILED. THREE SIZES WERE SUCCESSFULLY DEPLOYED. ALL DEVICES WE PREPARED AS INDICATED IN THE IFU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A AVANTI 6F SHEATH, OMNI SOS GUIDE CATHETER, RENEGADE HIGH FLOW MICRO CATHETER, FATHOM GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047380 ↗
• MalfunctionMar 16, 2026Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE COIL WAS USED TO TREAT A BLEEDING AFTER A HIP TOTAL ENDOPROSTHESIS (TEP). THE COIL COULD NOT BE PUSHED THROUGH THE PROGREAT 2.4. THERE WAS A RESISTANCE IN THE DISTAL PART OF THE MICROCATHETER. THEREFORE NO IMPLANT OF THE COIL WAS POSSIBLE. THE PHYSICIAN USED AN NV-2-4-HELIX TO COMPLETE THE PROCEDURE (WITH THE SAME MICROCATHETERS) WITHOUT ANY PROBLEMS. THE REPORT WAS CLARIFIED THAT THE COIL COULD NOT BE DELIVERED AND DEPLOYED BECAUSE OF RESISTANCE. THE INITIAL INFORMATION REPORTED WAS INCORRECT. NO CONTINUOUS FLUSH WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608072 ↗
• MalfunctionMar 13, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING AN ATTEMPT TO ADVANCE A CONCERTO NV-2-6-HELIX COIL THROUGH A PHENOM 21 MICROCATHETER, THE COIL COULD NOT BE ADVANCED INTO THE MICROCATHETER. EVEN AFTER THE PROTECTIVE SHEATH WAS FULLY ADVANCED TO THE BASE OF THE MICROCATHETER HUB, THE COIL COULD NOT BE DELIVERED SMOOTHLY. THE COIL WAS REPLACED WITH A CONCERTO NV-2-8-HELIX COIL, HOWEVER, THE SAME RESISTANCE WAS ENCOUNTERED. THE COIL WAS REPLACED WITH A NON-MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT FOR HYPOPHARYNGEAL CANCER TUMOR. 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). ANCILLARY DEVICES INCLUDED RSR18 GUIDECATHETER, ASAHI WAMS-180-16ST GUIDEWIRE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. RESISTANCE WAS ENCOUNTERED AT THE HUB PORTION OF THE CATHETER. THE COIL EXITED THE PROTECTIVE SHEATH SMOOTHLY, AND A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592708 ↗
• MalfunctionFeb 13, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER AND THE MANUAL METHOD WITH THE HYPOTUBE 2 TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH A SECOND INSTANT DETACHER DEVICE. IT WAS INDICATED THAT THE REPORTED DEVICE WAS NOT PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), NOTED AS NO CONTINUOUS FLUSH PREFORMED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333001 ↗
• MalfunctionFeb 5, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WOULD NOT DETACH. THE INSTANT DETACHER WAS NOT USED TO ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THE MANUAL METHOD WAS ATTEMPTED NUMEROUS TIMES. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THERE WAS NON-DETACHMENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A PROGREAT MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268481 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO HELIX COIL WAS DETACHED BEFORE USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. IT WAS UNKNOWN WHAT CONDITION WAS BEING TREATED OR WHAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE. 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 24136726 ↗
• MalfunctionJan 20, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING INTERVENTIONAL RADIOLOGY AND VASCULAR SURGERY SUPPORT FOR AN INFERIOR EPIGASTRIC BLEED. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE UNKNOWN. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THAT REQUIRED THE USE OF EIGHT EV3 CONCERTO COILS TO EMBOLIZE THE VESSEL. THERE WERE ISSUES INTRODUCING THREE 2MMX6CM HELIX COILS INTO A TRUSELECT MICROCATHETER, TWO OF THE COILS WOULD NOT GO PASSED THE HUB OF THE MICROCATHETER AND ONE WAS SEIZED WITHIN THE CATHETER AT THE DISTAL END. IT WAS UNKNOWN WHETHER THE IMPLANT COIL WAS PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THIS RESULTED IN THE REMOVAL OF THE TRUSELECT MICROCATHETER WHERE THE COIL AND THE CATHETER WERE FOUND TO BE INTACT. WHEN THE SECOND TRUSELECT WAS INSERTED, AND THE CORRECT VESSEL WAS RESELECTED, THE THIRD CONCERTO COIL INTRODUCTION WAS ATTEMPTED BUT FAILED TO GET PASSED THE HUB OF THE NEW MICROCATHETER. THE EMBOLIZATION OF THE VESSEL WAS OBTAINED BY USING A DIFFERENT BRAND COIL. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE REPORTED DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126624 ↗
• MalfunctionJan 16, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL DID NOT DETACH. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101906 ↗
• MalfunctionJan 16, 2026Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094364 ↗
• MalfunctionNov 26, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THREE CONCERTO COILS EXPERIENCED RESISTANCE IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A LEFT RENAL ANGIOGRAM WITH A POSSIBLE PSEUDO ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE CONCERTO COILS WOULD NOT TRACK THROUGH THE MICRO CATHETER. THE PHYSICIAN FELT RESISTANCE AND COULD NOT ADVANCE THE COILS. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY DEPLOY OTHER COILS AFTER THIS EVENT THROUGH THE SAME MICROCATHETER. NEITHER THE COIL NOR THE CATHETER WERE DAMAGED. 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 STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. CATHETER RESISTANCE WAS AT THE HUB. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS FLUSHED IN BETWEEN THE USE OF COILS. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN. ANCILLARY DEVICES INCLUDE A SHEATH: 5FR PINNACLE, AND A MICROCATHETER: 2FR TRUE SELECT. ADDITIONAL INFORMATION RECEIVED REPORTED THE COILS PASSED THROU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659751 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT'S BASELINE WAS NORMAL/THE FISTULA WAS IN THE PATIENT'S DIALYSIS GRAFT IN THE UPPER EXTREMITY. THERE WAS NOT A POST THROMBECTOMY CONDITION. THE CAUSE OF THE RESISTANCE WAS BELIEVED TO BE DUE TO NOT HYDRATING THE COIL BEFORE THE INTRODUCTION INTO THE MICROCATHETER. THE CAUSE OF THE PREMATURE DEPLOYMENT WAS DUE TO RESISTANCE IN THE MICROCATHETER AND FORWARD FORCE. THE COIL SEEMED TO MOVE FREELY OUT OF THE COIL INTRODUCER SHEATH. THE INFORMATION WAS PROVIDED BY THE SCRUB ASSISTANT IN THE PROCEDURE. THREE OTHER COILS WERE PLACED AFTER THE RESISTANCE/PREMATURE DEPLOYMENT WITH A NEW MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623883 ↗
• MalfunctionNov 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT WAS BEING USED AS PER THE INSTRUCTIONS FOR USE (IFU), HOWEVER, THE CONCERTO HELIX COIL GOT STUCK WITHIN THE MICROCATHETER. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE CATHETER WAS NOT A MEDTRONIC PRODUCT. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. 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 23560672 ↗
• MalfunctionNov 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO HELIX COIL COULD NOT BE ADVANCED. 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. THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513586 ↗
• MalfunctionNov 3, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT NV-2-4-HELIX (BATCH NO: 231316177) WAS DISCOVERED KINKED UPON OPENING THE PACKAGE. THERE WAS PUSHER KINK/BROKEN. THE DAMAGED LOCATION WAS THE PUSHWIRE MIDDLE SEGMENT. ANOTHER COIL NV-2-6-HELIX (BATCH NO: 231221824) WAS UNABLE TO DEPLOY. THERE WAS NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER TWO TIMES. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. ANOTHER COIL NV-2-6-HELIX (BATCH NO: 231221824) WAS DISCOVERED KINKED UPON OPENING. THERE WAS PUSHER KINK/BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED SECTION WAS THE PUSHWIRE MIDDLE SEGMENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED 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 ANEURYSM. ANCILLARY DEVICES INCLUDE A TERUMO SHEATH, BOSTON TRUSLECT MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458266 ↗
• MalfunctionJul 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL CONCERTO COULD NOT BE ADVANCED. IT WAS REPORTED THAT THE REPORTED DEVICE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE. CAUSE OF THE RESISTANCE WAS UNKNOWN. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683462 ↗
• MalfunctionJul 22, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT WAS BEING USED AS PER THE INSTRUCTIONS FOR USE (IFU) BUT THE COIL WAS KINKED AND GOT STUCK WITHIN THE MICROCATHETER. A NEW MEDTRONIC DEVICE WAS USED TO FINISH THE PROCEDURE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER WAS NOT A MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572967 ↗
• MalfunctionJul 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CONCERTO COIL COULD NOT PASS THROUGH THE MICROCATHETER DURING THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE 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. ANCILLARY DEVICE USE WAS A MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE CATHETER HUB. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE OBSERVED TO THE COIL OR CATHETER. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512802 ↗
• MalfunctionMay 31, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED CAN'T CONFIRM IF THE COIL WOULD BE ABLE TO DETACH. THERE WAS RESISTANCE WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE COIL TO DEPLOY IT, HOWEVER SINCE THERE'S NO SUCCESSFUL DEPLOYMENT, THERE WAS NO ATTEMPT TO DETACH IT. A COIL HAS TO BE SUCCESSFULLY DEPLOYED INTO THE VESSEL BEFORE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120467 ↗
• MalfunctionMay 27, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS A DETACH DEFECT WITH A CONCERTO COIL. 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 22087994 ↗
• MalfunctionFeb 26, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE COIL CONCERTO HELIX 2MM X 6CM, THE COIL COULD NOT BE ADVANCED. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470992 ↗
• MalfunctionJan 21, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING THE USE OF THE COIL CONCERTO HELIX 2 MM X 6 CM, THE DEVICE WOULD NOT DEPLOY, AND THERE WAS A NON-DETACHMENT OF THE COIL. THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE INSTANT DETACHER WAS DISCARDED, AND IT IS UNKNOWN IF THERE WAS ANY ISSUE WITH IT. THE PRODUCT WAS REPLACED BY ANOTHER MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200779 ↗

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