ConcertoTM PV-14-30-HELIX (UDI 00847536017016)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536017016), received between Apr 19, 2019 and May 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• MalfunctionMay 27, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT A DURING A PROCEDURE, THE CONCERTO COIL WAS NOT FORMING LOOPS AS EXPECTED SO THE DEVICE WAS WITHDRAWN AND REPLACED WITH A NEW MEDTRONIC DEVICE. IT WAS NOTED THAT THE CONCERTO COIL AND ALL ACCESSORY DEVICES USED WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898292 ↗
• MalfunctionApr 19, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PV-14-30-HELIX WAS SUCCESSFULLY INSERTED AND ADVANCED THROUGH THE MICROCATHETER UNDER THE INSTRUCTIONS FOR USE (IFU) PROCEDURE. HOWEVER, BEFORE THE COILS CAME OUT FROM THE DISTAL LUMEN OF THE MICROCATHETER FOR DEPLOYMENT, THE SURGEONS FELT A HUGE RESISTANCE IN DELIVERING THE COIL OUT OF THE MICROCATHETER INTO THE INTERNAL ILIAC ARTERY. HENCE, THE SURGEON DIRECTLY PULLED OUT THE COIL AND TRIED THE PROCEDURE AGAIN, BUT THE DELIVERY STILL FAILED. THE DEVICE WAS REPLACED WITH A PV-12-30-HELIX WHERE IT WAS SUCCESSFULLY INSERTED AND ADVANCED THROUGH THE MICROCATHETER UNDER IFU PROCEDURE. HOWEVER, BEFORE THE COILS CAME OUT FROM THE DISTAL LUMEN OF THE MICROCATHETER FOR DEPLOYMENT, THE SURGEONS AGAIN FELT A HUGE RESISTANCE IN DELIVERING THE COIL OUT OF THE MICROCATHETER INTO THE INTERNAL ILIAC ARTERY. HENCE, THE DEPLOYMENT FAILED. ALSO, THE PV-12-30-HELIX COULD NOT BE PULLED OUT DUE TO THE RESISTANCE, AND THUS THE COIL WAS KEPT IN THE MICROCATHETER THE DEVICE WAS REPLACED WITH A PV-12-30-HELIX. IT WAS NOTED THAT THERE WAS NO DAMAGE WITH THE EITHER THE CATHETERS OR COILS. THE PATIENT WAS UNDERGOING SURGERY FOR AN EMBOLIZATION OF THE INTERNAL ILIAC ARTERY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8531882 ↗