ConcertoTM NV-4-8-HELIX (UDI 00847536013438)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536013438), received between Jun 28, 2019 and Sep 27, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PROCEDURE COULD NOT BE PERFORMED BECAUSE THE COIL DID NOT ENTER THE MICROCATHETER WHILE PERFORMING THE PROCEDURE IN ACCORDANCE WITH THE IFU. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9130389 ↗
• 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 8745503 ↗