ConcertoTM NV-5-15-HELIX (UDI 00847536013490)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536013490), received between Jan 28, 2019 and Jan 6, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE COIL INTO THE MICROCATHETER AND WHEN PULLED BACK INTO THE DELIVERY CATHETER THE COIL WAS DETACHED AT THE CATHETER HUB. USED ANOTHER COIL SAME SIZE AND WERE ABLE TO DEPLOY. THE EVENT HAPPENED OUTSIDE THE PATIENT. THE PATIENT'S UNDERWENT EMBOLIZATION TREATMENT FOR PATENT WITH GLENN AND AP COLLATERALS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9554445 ↗
• MalfunctionNov 20, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE COIL FAILURE TO DETACH. IT WAS ALSO NOTED THAT THE COIL WAS NOT HYDRATED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DETAILS ON THE ANEURYSM GIVEN AND NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE STAFF IS BEING RE-TRAINED MAKE SURE THEY FOLLOW THE STEPS PER THE INSTRUCTIONS FOR USE (IFU). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9349182 ↗
• MalfunctionOct 17, 2019Difficult or Delayed Positioning; Separation Failure; Physical Resistance/Sticking; Difficult or Delayed Positioning; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO HELIX COIL HAD RESISTANCE WHEN ADVANCING THROUGH THE STC18 MICROCATHETER, AND WOULD NOT DEPLOY ONCE POSITIONED. THE COIL WAS STUCK IN THE CATHETER, BUT THE LOCATION IN THE CATHETER WAS UNKNOWN. IT WAS UNKNOWN IF THERE WAS ANY CATHETER OR COIL DAMAGE, BUT NON-DETACHMENT WAS INDICATED. IT WAS UNKNOWN HOW MANY TIMES THE COIL DETACHMENT WAS ATTEMPTED OR IF A MANUAL ATTEMPT WAS PERFORMED. IT WAS UNKNOWN IF THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE AN STC18 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9202942 ↗
• MalfunctionMar 25, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL WAS PREPARED PER THE INSTRUCTIONS FOR USED BUT WAS UNABLE TO BE USED AS IT WAS STRETCHED OUT. NO PATIENT INJURY OCCURRED. THE CUSTOMER WAS NOTIFIED TO RETURN THE DEVICE. THE DEVICE WAS REPORTED TO HAVE BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE. NO ADDITIONAL INFORMATION IS AVAILABLE (LEGAL/CONFIDENTIAL REASON).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8447995 ↗
• MalfunctionJan 28, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL FAILED TO DETACH WITH THE INSTANT DETACHER AND VIA MANUAL METHOD. THE COIL WAS REMOVED. NO PATIENT INJURY OCCURRED. IT IS UNKNOWN HOW MANY ATTEMPTS WERE MADE WITH THE INSTANT DETACHER OR VIA MANUAL DETACHMENT. ALL OTHER EVENT DETAILS ARE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8282567 ↗