Concerto Detachable Coil System NV-3-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00847536044906), received between Mar 28, 2022 and Aug 20, 2026 — classified as 3 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (39 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 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Break; Stretched; Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50347051 ↗
• MalfunctionAug 7, 2026Physical Resistance/Sticking

  Medtronic received a report that the Concerto coil could not be advanced. The procedure was completed by using a new product, and the causes or contributing factors for the coil not advancing were not identified. 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 50183239 ↗
• MalfunctionJul 20, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882890 ↗
• MalfunctionJun 11, 2026Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE JOSE CARINO (INVENTORY) RELAYED INFORMATION FROM DR. SHAHIN. SAID THE CONCERTO COIL WOULDN¿T DETACH, IT WAS ALSO NOTED THAT THE DIDN'T DEPLOY. THEY PULLED BACK A LITTLE, COULDN'T PUT IT THROUGH AGAIN. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480369 ↗
• MalfunctionJun 10, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO HELIX COIL WAS BEING USED AS PER THE IFU BUT THE COIL WAS KINKED AND GOT STUCK WITHIN THE MICROCATHETER. A NEW MEDTRONIC DEVICE WAS USED TO FINISH THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE UNKNOWN. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSES OR CONTRIBUTING FACTORS FOR THE KINK OR RESISTANCE WERE NOT IDENTIFIED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE REPORTED STATEMENT OF "NO ALLEGED PRODUCT ISSUE" FOR THE COIL WAS CLARIFIED TO BE AS FOLLOWS: THERE COULD HAVE BEEN AN ISSUE WITH THE COIL BUT IT IS UNCLEAR. THIS INFORMATION HAS BEEN CONFIRMED/PROVIDED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461848 ↗
• MalfunctionJun 9, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO HELIX COIL WAS BEING USED AS PER THE IFU BUT THE COIL WAS KINKED AND GOT STUCK WITHIN THE MICROCATHETER. A NEW MEDTRONIC DEVICE WAS USED TO FINISH THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE UNKNOWN. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSES OR CONTRIBUTING FACTORS FOR THE KINK AND RESISTANCE WERE NOT IDENTIFIED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE REPORTED STATEMENT OF "NO ALLEGED PRODUCT ISSUE" FOR THE COIL WAS CLARIFIED TO BE AS FOLLOWS: THERE COULD HAVE BEEN AN ISSUE WITH THE COIL BUT IT IS UNCLEAR. THIS INFORMATION HAS BEEN CONFIRMED/PROVIDED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449078 ↗
• MalfunctionMay 4, 2026Break; Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL "CUT OFF." THE PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT ARE UNKNOWN. THE PATIENT'S VESSEL TORTUOSITY WAS UNKNOWN. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069324 ↗
• MalfunctionMay 1, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A PROSTATE ARTERY EMBOLIZATION. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT CONCERTO COIL WAS INSERTED AND ADVANCED INTO MICROCATHETER. ON ADVANCING COIL, THERE WAS SIGNIFICANT RESISTANCE ON DELIVERY AT THE DISTAL SECTION OF THE CATHETER, SCANNED TO OBSERVE THE COIL AND IT HAD DETACHED PREMATURELY IN THE MICROCATHETER. NO DAMAGE OBSERVED IN THE COIL AND CATHETER. IT WAS UNKNOWN IF 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 PROGREAT 1.9FR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056004 ↗
• MalfunctionMar 13, 2026Therapy Delivered to Incorrect Body Area; Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF A CONCERTO COIL THAT ENCOUNTERED RESISTANCE, BECAME STUCK IN THE SHEATH, AND STARTED TO COIL IN THE S HEATH. IT WAS REPORTED THAT 3 X 8 COILS WOULD NOT PUSH AND THEN 1 OF THEM STARTED COILING IN THE SHEATH. SO THE PHYSICIAN HAD TO EXCHANGE CATHETERS AND USE PENUMBRA. IT WAS NOTED THAT THERE WAS COIL RESISTANCE/STUCK IN SHEATH. 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. ANCILLARY DEVICES INCLUDE A NON-MEDTRONIC TERUMO PROGREAT 2.4 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589869 ↗
• MalfunctionMar 6, 2026Compatibility Problem; Physical Resistance/Sticking

  ]MEDTRONIC RECEIVED REPORT THAT DURING A HEMORRHOID EMBOLIZATION PROCEDURE, THE CONCERTO COIL COULD NOT BE COMPLETELY REMOVED FROM THE SHEATH AND HAD RESISTANCE AT THE PROXIMAL END OF THE MICROCATHETER. THERE WAS NO DAMAGE OBSERVED TO THE COIL OR THE CATHETER. NO PATIENT INFORMATION WAS REPORTED OR AVAILABLE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. IT WAS STATED THAT THEY TOOK THE WRONG SIZE OF MICROCATHETER. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND CATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL WAS ATTEMPTED TO BE USED WITH AN INCOMPATIBLE CATHETER SIZE. THEY TOOK THE WRONG SIZE OF MICRO CATHETER, SO THE COIL DID NOT WORK CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531598 ↗
• MalfunctionJan 26, 2026Separation Failure; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ENDOLEAK WAS LOCATED AS A POST-EVAR TYPE II ENDOLEAK. THE COILS DID NOT DEPLOY BECAUSE RESISTANCE WAS FELT WHEN ATTEMPTING TO INSERT THEM INTO THE MICROCATHETER. KINKING WAS FOUND AFTER A FEW ATTEMPTS. PRIOR TO COIL NON-DETACHMENT, RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO INSERT THE COIL INTO THE MICROCATHETER. AFTER REMOVAL FROM THE PATIENT, KINKING WAS OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183281 ↗
• MalfunctionJan 26, 2026Separation Failure; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO HELIX COILS WOULD NOT DEPLOY. IT WAS ALSO REPORTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE. THE PRODUCT WAS REPLACED WITH A DIFFERENT MODEL MEDTRONIC COIL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN ENDOLEAK. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED A MERIT MAESTRO MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183273 ↗
• MalfunctionJan 23, 2026Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE INITIAL REPORT WAS COIL WOULD NOT DETACH. AFTER FURTHER VERIFICATION THE COIL WOULD NOT ADVANCE THROUGH THE CATHETER THEREFORE WAS NOT DETACHED. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THIS INFORMATION WAS CONFIRMED BY THE IR SCRUB THAT WAS IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163448 ↗
• MalfunctionJan 15, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL EXPERIENCED RESISTANCE. THE PATIENT WAS UNDERGOING TREATMENT FOR A GASTROINTESTINAL BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE CONCERTO COIL WAS RETRIEVED INTO THE SHEATH AFTER FIRST POSITIONING, WHEN THE DOCTOR WANTED TO USE IT AGAIN, IT WAS DISCOVERED THE COIL COULD NOT INSERT INTO THE MICROCATHETER AND BECAME STUCK IN THE SHEATH. 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 RECEIVED REPORTED THE CAUSE OF THE COIL RESISTANCE WAS NOT DETERMINED. A CONTINUOUS CATHETER FLUSH WAS ADMINI STERED DURING THE PROCEDURE. THE COIL HAD RESISTANCE IN THE INTRODUCER SHEATH, NOT IN THE CATHETER. IT WAS NOTED THE COIL WAS "FULLY OF CLOTS" BUT DID NOT OTHERWISE APPEAR DAMAGED. THERE WAS NO DAMAGE TO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24089156 ↗
• MalfunctionJan 15, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL WAS STUCK IN THE CATHETER AND ENCOUNTERED RESISTANCE IN THE SHEATH. THE PRODUCT BECAME STUCK INSIDE THE CATHETER DURING THE PROCEDURE AND THE COIL DID NOT ADVANCE; IT WAS REPLACED WITH A NEW ONE, 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 COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082946 ↗
• MalfunctionJan 9, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THREE CONCERTO HELIX COILS (N=1 NV-2-8-HELIX, N=2 NV-3-8-HELIX) AND ONE CONCERTO 3D COIL (PV-3-8-3D) MET RESISTANCE\BECAME STUCK IN THE PROXIMAL END OF A NON-MEDTRONIC MICROCATHETER AND WERE UNABLE TO BE ADVANCED. THE IMPLANT COILS PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH AND THERE WAS NO DAMAGE TO THE COILS OR THE CATHETER. ADDITIONALLY, A CONCERTO HELIX COIL (NV-6-20-HELIX) MET RESISTANCE FROM THE POINT OF INITIAL ADVANCEMENT THROUGH THE SAME NON-MEDTRONIC MICROCATHETER AND WAS UNABLE TO BE ADVANCED PAST THE MIDDLE SECTION OF THE MICROCATHETER. UPON REMOVAL OF THE COIL, IT WAS OBSERVED THAT THE MIDDLE SEGMENT OF THE DELIVERY PUSHWIRE WAS KINKED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE SAME MICROCATHETER WAS USED TO FINISH THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN ENDOLEAK. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED TRUSELECT¿ MICROCATHETER. ADDITIONAL INFORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020337 ↗
• MalfunctionOct 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT FOR OCCLUSION OF AORTIC-PULMONARY COLLATERAL ARTERIES USING A CONCERTO COIL, PREMATURE COIL DETACHMENT OCCURRED. THE COIL WAS RELEASED UPON TRANSFER TO THE MICROCATHETER, AND FLUOROSCOPY WAS USED TO OBSERVE THE COIL SEPARATION. THE COIL WAS SEEN TO SEPARATE FROM THE WIRE, PROMPTING REMOVAL OF THE MICROCATHETER WITH THE COIL INSIDE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, NO PUSHWIRE BENDING OR BREAKING, AND NO REPOSITIONING OR ROTATION OF THE DELIVERY PUSHER. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED, AND THE PATIENT¿S BLOOD FLOW REMAINED NORMAL WITH MODERATE VESSEL TORTUOSITY. THE PATIENT WAS ALIVE WITH NO INJURY, SYMPTOMS, OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDED A REBAR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380722 ↗
• 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 23329710 ↗
• 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 23329687 ↗
• MalfunctionOct 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO HELIX COIL COULD NOT BE ADVANCED. 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). ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328861 ↗
• MalfunctionSep 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO HELIX COIL RELEASED FROM THE WIRE INSIDE THE NON-MEDTRONIC MICROCATHETER. COIL SEPARATI ON/BREAK/PREMATURE DETACHMENT WAS NOTED. THE COIL WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY FOR TREATMENT OF AORTOPULMONARY COLLATERAL VESSELS. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL. THE DELIVERY PUSHER WAS NOT ROTATED DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. ANCILLARY DEVICES INCLUDE: COBRA 5F GUIDE CATHETER, EXCELSIOR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063925 ↗
• MalfunctionSep 11, 2025Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT THE COIL CONCERTO HELIX 3MM X 8CM DEVICE WAS FOUND TO BE KINKED WHILE OPENING. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031377 ↗
• MalfunctionSep 8, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE COIL CONCERTO HELIX 3MM X 8CM AND COIL CONCERTO HELIX 5MM X 20CM, THE COILS WOULD NOT PASS THROUGH THE COIL DELIVERY SHEATH. THIS ISSUE OCCURRED WITH BOTH PRODUCTS, IDENTIFIED AS NV-3-8-HELIX AND NV-5-20-HELIX. THE STAFF NOTED COIL RESISTANCE/STUCK AND INSTANCES OF COIL KINK OR DAMAGE. DESPITE THESE ISSUES, OTHER CONCERTO COILS WERE USED SUCCESSFULLY IN THE CASE. THE DEFECTIVE PRODUCTS WERE NOT IMPLANTED AND WERE REPLACED BY MEDTRONIC PRODUCTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES: SHEATH, MICROCATHETER, GUIDEWIRE ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS SALINE FLUSH WAS NOT ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IFU PREP AND USE FOR COILS WAS DISCUSSED, AND AN IN-SERVICE IS SCHEDULED TO GO OVER IN FURTHER DETAIL. STAFF DID NOT BELIEVE THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS SALINE FLUSH WAS NOT ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. IFU PREP AND USE FOR COILS WAS DISCUSSED. THE STAFF DID NOT BELI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998688 ↗
• MalfunctionAug 14, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE CONCERTO COIL HAD RESISTANCE AND THE PUSHWIRE WAS KINKED. IT WAS REPORTED THAT THE CONCERTO COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL DEVICE HAD FRICTION/DIFFICULTY DURING TESTING OR DELIVERY AND IT WAS NOTED THAT THE MIDDLE PART OF THE PUSHWIRE KINKED. THE CONCERTO WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE PROXIMAL SECTION OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. KINK/DAMAGE WAS OBSERVED TO THE CATHETER AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT. 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 22801449 ↗
• MalfunctionJul 14, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE REINSERTION OF THE COIL CONCERTO HELIX 3MM X 8CM INTO THE MICROCATHETER, THE COIL BUCKLED AND RESISTANCE WAS FELT. ADDITIONALLY, THE PUSHWIRE WAS FOUND TO BE SLIGHTLY KINKED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE OCCURRED IN THE MIDDLE SEGMENT OF THE CATHETER. THERE WAS NO KINK/DAMAGE OBSERVED TO THE CATHETER AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC DEVICE. IT WAS NOTED THAT DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THE CAUSE OF THE RESISTANCE AND COIL DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22499517 ↗

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