Concerto Detachable Coil System NV-4-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536044913), received between Feb 7, 2023 and Feb 16, 2026 — classified as 8 injuries, 4 malfunctions.

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

• InjuryFeb 16, 2026Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS DETACHED USING THE DETACHER. IT WAS STATED THAT THE PATIENT HAD PRESENTED WITH ABDOMINAL PAIN AND THE AREA COILED WAS AN INCIDENTAL FINDING THAT COULD HAVE BEEN THE CAUSE AND SO THE COILING PROCEDURE WAS DONE. THE PATIENT RETURNED WITH ABDOMINAL PAIN, BUT THE DOCTOR DID NOT KNOW IF IT WAS THE SAME PAIN OR DIFFERENT. THE ABDOMINAL CT FOUND THE FILAMENT EXTENDING FROM THE INITIAL COIL THROUGH THE OTHER COILS INTO THE AORTA AND DOWN INTO THE EXTERNAL ILIAC AREA. IT IS NOT KNOWN IF ANTICOAGULANTS WERE ADMINISTERED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24353093 ↗
• InjuryFeb 16, 2026Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS DETACHED USING THE DETACHER. IT WAS STATED THAT THE PATIENT HAD PRESENTED WITH ABDOMINAL PAIN AND THE AREA COILED WAS AN INCIDENTAL FINDING THAT COULD HAVE BEEN THE CAUSE AND SO THE COILING PROCEDURE WAS DONE. THE PATIENT RETURNED WITH ABDOMINAL PAIN, BUT THE DOCTOR DID NOT KNOW IF IT WAS THE SAME PAIN OR DIFFERENT. THE ABDOMINAL CT FOUND THE FILAMENT EXTENDING FROM THE INITIAL COIL THROUGH THE OTHER COILS INTO THE AORTA AND DOWN INTO THE EXTERNAL ILIAC AREA. IT IS NOT KNOWN IF ANTICOAGULANTS WERE ADMINISTERED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24353020 ↗
• InjuryFeb 16, 2026Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS DETACHED USING THE DETACHER. IT WAS STATED THAT THE PATIENT HAD PRESENTED WITH ABDOMINAL PAIN AND THE AREA COILED WAS AN INCIDENTAL FINDING THAT COULD HAVE BEEN THE CAUSE AND SO THE COILING PROCEDURE WAS DONE. THE PATIENT RETURNED WITH ABDOMINAL PAIN, BUT THE DOCTOR DID NOT KNOW IF IT WAS THE SAME PAIN OR DIFFERENT. THE ABDOMINAL CT FOUND THE FILAMENT EXTENDING FROM THE INITIAL COIL THROUGH THE OTHER COILS INTO THE AORTA AND DOWN INTO THE EXTERNAL ILIAC AREA. IT IS NOT KNOWN IF ANTICOAGULANTS WERE ADMINISTERED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24352961 ↗
• InjuryFeb 16, 2026Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS DETACHED USING THE DETACHER. IT WAS STATED THAT THE PATIENT HAD PRESENTED WITH ABDOMINAL PAIN AND THE AREA COILED WAS AN INCIDENTAL FINDING THAT COULD HAVE BEEN THE CAUSE AND SO THE COILING PROCEDURE WAS DONE. THE PATIENT RETURNED WITH ABDOMINAL PAIN, BUT THE DOCTOR DID NOT KNOW IF IT WAS THE SAME PAIN OR DIFFERENT. THE ABDOMINAL CT FOUND THE FILAMENT EXTENDING FROM THE INITIAL COIL THROUGH THE OTHER COILS INTO THE AORTA AND DOWN INTO THE EXTERNAL ILIAC AREA. IT IS NOT KNOWN IF ANTICOAGULANTS WERE ADMINISTERED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24352706 ↗
• InjuryFeb 16, 2026Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS DETACHED USING THE DETACHER. IT WAS STATED THAT THE PATIENT HAD PRESENTED WITH ABDOMINAL PAIN AND THE AREA COILED WAS AN INCIDENTAL FINDING THAT COULD HAVE BEEN THE CAUSE AND SO THE COILING PROCEDURE WAS DONE. THE PATIENT RETURNED WITH ABDOMINAL PAIN, BUT THE DOCTOR DID NOT KNOW IF IT WAS THE SAME PAIN OR DIFFERENT. THE ABDOMINAL CT FOUND THE FILAMENT EXTENDING FROM THE INITIAL COIL THROUGH THE OTHER COILS INTO THE AORTA AND DOWN INTO THE EXTERNAL ILIAC AREA. IT IS NOT KNOWN IF ANTICOAGULANTS WERE ADMINISTERED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24352654 ↗
• InjuryFeb 16, 2026Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS DETACHED USING THE DETACHER. IT WAS STATED THAT THE PATIENT HAD PRESENTED WITH ABDOMINAL PAIN AND THE AREA COILED WAS AN INCIDENTAL FINDING THAT COULD HAVE BEEN THE CAUSE AND SO THE COILING PROCEDURE WAS DONE. THE PATIENT RETURNED WITH ABDOMINAL PAIN, BUT THE DOCTOR DID NOT KNOW IF IT WAS THE SAME PAIN OR DIFFERENT. THE ABDOMINAL CT FOUND THE FILAMENT EXTENDING FROM THE INITIAL COIL THROUGH THE OTHER COILS INTO THE AORTA AND DOWN INTO THE EXTERNAL ILIAC AREA. IT IS NOT KNOWN IF ANTICOAGULANTS WERE ADMINISTERED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24352575 ↗
• InjuryJan 22, 2026Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION WAS A PSEUDO-ANEURYSM IN THE INFERIOR PANCREATICODUODENAL REGION. WHEN THE PRESENCE OF THE FILAMENT WAS NOTED, THE DECISION WAS MADE TO ADMINISTER ANTICOAGULANTS RATHER THAN RE-INTERVENE. ANTICOAGULANTS WERE GIVEN ON (B)(6) TO ADDRESS BOTH THE FILAMENT AND THE ABDOMINAL PAIN, WHICH BEGAN ON (B)(6) AND RESOLVED BY (B)(6). THE IMPLANT PROCEDURE WAS BELIEVED TO HAVE OCCURRED ON (B)(6), WITH FOLLOW-UP CT IMAGING PERFORMED ON (B)(6)7. REGARDING THE COILS, IT WAS REPORTED THAT FOUR CONCERTO HELIX 4MM X 8CM COILS (MODEL NUMBER: NV-4-8-HELIX, LOT NUMBER: 230942604) WERE IMPLANTED, BUT ONLY ONE HAD THE FILAMENT STILL ATTACHED. ADDITIONAL COILS INCLUDED NV-6-20-HELIX (LOT: 232195914), NV-4-8-HELIX (LOT: 231168010) X2, AND NV-4-8-HELIX (LOT: 227894258), THOUGH IT IS UNCLEAR WHICH SPECIFIC DEVICE WAS INVOLVED IN THE ISSUE. THE CAUSE OF THE NON-DETACHMENT OF THE COIL FILAMENT WAS NOT DETERMINED, THOUGH POSSIBLE OPTIONS WERE DISCUSSED WITH ENGINEERING. THE CAUSE OF THE ABDOMINAL PAIN IS STILL TO BE DETERMINED. ONE ATTEMPT WAS MADE TO DETACH THE COIL USING THE INSTANT DETACHER AND ONE ATTEMPT USING THE MANUAL METHOD, AS PER USUAL PRACTIC

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24148976 ↗
• MalfunctionJun 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL HELIX DEVICE 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 RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286830 ↗
• MalfunctionMar 25, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A CONCERTO COIL, THE COIL WAS NOT DEPLOYED DUE TO RESISTANCE AND IT BECAME STUCK IN THE CATHETER. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT VESSEL TORTUOSITY WAS MODERATE AND THE PATIENT IS ALIVE WITH NO INJURY. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE WELL. CATHETER RESISTANCE OCCURRED IN THE MIDDLE SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER USED WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692102 ↗
• MalfunctionDec 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS RECOVERING FROM THE PROCEDURE "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028809 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE IS NO INFORMATION ON THE INDEX PROCEDURE CRF TO INDICATE THAT THE COIL USED HAD ANY ISSUE AS IT IS NOTED THAT IT SUCCESSFULLY TREATED THE TARGET VESSEL, NO ANCILLARY PROCEDURES WERE PERFORMED, AND THE DEVICE DEPLOYED SUCCESSFULLY. SAFETY HAS SENT A QUERY TO STUDY MANAGEMENT ASKING THEM TO CLARIFY WITH THE SITE IF THE ADMINISTRATION OF A POST-PROCEDURE BLOOD TRANSFUSION WAS DUE TO ANY ADVERSE EVENT (AE) OR DEVICE DEFICIENCY(DD). SAFETY HAS ALSO ASKED STUDY MANAGEMENT TO CLARIFY WITH THE SITE WHY A POST-PROCEDURE BLOOD TRANSFUSION WAS GIVEN AND IF IT WAS DUE TO AN AE OR DD, AND ALSO TO CLARIFY WHAT CAUSED THE POST-PROCEDURE BLEEDING, IF ANY DID OCCUR, AS THIS IS CURRENTLY NOT CONFIRMED. NO RESPONSE TO THE QUERY HAS BEEN RECEIVED AS OF TODAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17712546 ↗
• MalfunctionFeb 7, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT TWO CONCERTO COILS FAILED TO DETACH. ONCE THE COIL WAS IN THE DESIRED LOCATION WITHIN THE VESSEL, THE PHYSICIAN TRIED TO DETACH THE COIL BY SNAPPING THE SHORT BLACK MARKER. FOR BOTH THE COILS RELATED TO THIS COMPLAINT, THE HYPOTUBE BROKE BUT THE COIL DID NOT DETACH. THE PHYSICIAN THEN USED A PAIR OF STERILE SCISSORSTO CUT THE PUSHER WIRE AND DETACH THE COILS. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) WITH NO ISSUES IDENTIFIED. THE PATEINT WAS BEING TREATED FOR A LESION IN THE LEFT SPLENIC ARTERY. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312573 ↗

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