ConcertoTM NV-2-6-HELIX (UDI 00847536013322)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847536013322), received between Jun 3, 2019 and Sep 16, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (10 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT PASS THROUGH THE MICROCATHETER. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER USED IN THE EVENT WAS NOT MANUFACTURED BY MEDTRONIC. NO NEW EVENT INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439827 ↗
• MalfunctionMar 29, 2022Product Quality Problem; Separation Failure; Product Quality Problem; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH FROM THE MICROCATHETER THAT WAS USED IN THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945368 ↗
• MalfunctionFeb 9, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. THERE WERE NO DETACHMENT ATTEMPTS MADE, AND ANY DAMAGE WAS OBSERVED IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300599 ↗
• MalfunctionJan 26, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THE DETACHABLE COIL SYSTEM FAILED TO DEPLOY. A NEW DEVICE WAS OBTAINED AND THE CASE CONTINUED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11230056 ↗
• MalfunctionJan 6, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT OF NON-DETACHMENT WITH A CONCERTO COIL. IT WAS REPORTED THAT THE COIL FAILED TO DETACH IN THE RIGHT HEPATIC ARTERY. THE PHYSICIAN ATTEMPTED TO DETACH WITH THE INSTANT DETACHER 3 TIMES. THE MANUAL METHOD WAS NOT ATTEMPTED. IT WAS STATED THAT THERE WERE NO ISSUES WITH THE INSTANT DETACHER, AND THE PATIENT WAS NOT INVOLVED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A BOSTON SCIENTIFIC STC 18 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128645 ↗
• MalfunctionDec 22, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SEVERAL ATTEMPTS HAD BEEN MADE WITH BOTH THE INSTANT DETACHER AND THE MANUAL METHOD. THERE WERE NO ISSUES PRIOR TO NON-DETACHMENT, AND THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056917 ↗
• MalfunctionJun 11, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER, VIA A MANUFACTURING REPRESENTATIVE, INDICATED THE COIL WAS NOT DETACHED IN THE VESSEL. USING THE SAME PRODUCTS, THE PROCEDURE WAS COMPLETED WELL, AND THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10143713 ↗
• MalfunctionJun 11, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER, VIA A MANUFACTURING REPRESENTATIVE, REPORTING THAT THE COIL WAS NOT DETACHED IN THE VESSEL. USING THE SAME PRODUCTS, THE PROCEDURE WAS COMPLETED WELL, AND THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10143469 ↗
• MalfunctionFeb 17, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL FAILED TO DETACH. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE CONCERTO COIL DID NOT DEPLOY UPON BENDING/BREAKING THE BACK OF THE WIRE. THE HEALTHCARE PROVIDER (HCP) ATTEMPTED THREE TIMES WITH THE INSTANT DETACHER, DID NOT USE A SECOND INSTANT DETACHER, THEN TRIED THE MANUAL DETACHMENT METHOD THREE TIMES. IT WAS STATED THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE COIL WAS EVENTUALLY REMOVED, AND A NEW COIL WAS INSERTED AND DEPLOYED WITH NO ISSUE. 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 9718723 ↗
• MalfunctionDec 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THIS CONCERTO COIL GOT STUCK IN THE MICROCATHETER AND WHEN IT WAS PULLED OUT, IT RELEASED ITSELF " NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9402410 ↗
• MalfunctionAug 30, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL FAILED TO DETACH FROM THE END OF THE MICROCATHETER. NO PATIENT INJURY REPORTED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8949395 ↗
• MalfunctionAug 12, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED ADDITIONAL EVENT INFORMATION: THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY OF BOTH BILATERAL INTERNAL MAXILLARY ARTERIES. THE VESSEL WAS REPORTEDLY NOT TORTUOUS. THE DEVICES HAD BEEN PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THREE DETACHMENT ATTEMPTS WERE MADE USING AN INSTANT DETACHER AND ONE ATTEMPT WAS MADE USING THE MANUAL METHOD. THESE ATTEMPTS WERE UNSUCCESSFUL IN DETACHING THE CONCERTO. THERE WERE REPORTEDLY NO ISSUES PRIOR TO NON-DETACHMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8885212 ↗
• MalfunctionJul 24, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT TWO CONCERTO COILS DID NOT FUNCTION AS DESIRED. THE COILS WERE REPORTED TO HAVE BEEN "DEFECTIVE/ BROKEN". THE COILS WERE NOT USED TO TREAT THE PATIENT. NO ADDITIONAL EVENT DETAILS ARE KNOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8823347 ↗
• MalfunctionJun 28, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH FROM THE MICROCATHETER. HOWEVER, AFTER REPLACING THE COIL, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE ANATOMY WAS REPORTED TO HAVE BEEN NORMAL. 2 TO 3 DETACH ATTEMPTS WERE MADE THE INSTANT DETACHER AND 2 TO 3 DETACHMENTS WERE MADE VIA THE MANUAL METHOD. ISSUES OCCURRED PRIOR TO THE DETACHMENT ATTEMPTS. NO DAMAGE WAS NOTED ON THE REMOVED PUSHWIRE. THE DEVICES WERE PREPARED AND USED PER THE IFU. ANCILLARY DEVICES INCLUDE A PROGREAT MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745658 ↗
• MalfunctionJun 3, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  MEDTRONIC RECEIVED A REPORT THAT TWO OF THE NV-2-8-HELIXS WOULD NOT LOAD, AND A NV-2-6-HELIX WAS FRAYED. THE PATIENT UNDER WENT COILING TREATMENT OF Y90 MAPPING RIGHT HEPATIC. THE PATIENT'S BLOOD FLOW WAS NORMAL. THE VESSEL WAS NORMAL TORTUOUS. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED PER THE IFU. THE COIL WAS HYDRATED PER THE IFU. PROGREAT 2.8 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8663128 ↗