ConcertoTM NV-9-30-HELIX (UDI 00847536013766)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536013766), received between Dec 17, 2019 and Jul 2, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING DEPLOYMENT A CONCERTO COIL WAS NOT FORMING LOOPS AS DESIRED. THE COIL AND ALL A CCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER MEDTRONIC COIL THAT WAS USED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111888 ↗
• MalfunctionJan 20, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT: THE COIL WAS DEPLOYED P ERFECTLY. AFTER REMOVAL OF THE PUSHWIRE, THERE WAS NO DAMAGE OBSERVED. THE COIL WAS EXPLANTED BY USING A SNARE TO RETRIEVE THE DEPLOYED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202828 ↗
• MalfunctionDec 17, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE AND A KINK IN THE PUSHER WIRE. IT WAS REPORTED THAT THE DOCTOR WAS UNSATISFIED WITH THE POSITION OF THE COIL, SO IT WAS WITHDRAWN BACK INTO THE PROGREAT27 MICROCATHETER TO REDEPLOY. HOWEVER, A LOT OF RESISTANCE WAS FELT. THE DOCTOR FELT IT WAS UNSAFE TO DEPLOY AND REMOVED THE COIL FROM THE PATIENT. UPON INSPECTION, IT WAS NOTICED A KINK IN THE PUSHER WIRE. 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 PROGREAT27 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9485441 ↗