RX NC TAKERU DC-RZ3015UA2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04540778170513), received between Feb 19, 2019 and Feb 19, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2019Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  CTO CASE WAS BEING PERFORMED WITH A HIGH CALCIUM LESION. THE PHYSICIAN WAS ABLE TO GET RADIAL ACCESS AND USED A GUIDE CATHETER (7FR, EBU 3.75) INTO THE LCA AND ADVANCED A GUIDEWIRE (ASAHI FIELDER XT, ASAHI INTECC) AND A TRAPLINER (TELEFLEX) DOWN THE CIRC. THE PHYSICIAN ADVANCED THE RX NC TAKERU OVER THE GUIDEWIRE TO THE CALCIFIED LESION. THE RX NC TAKERU WAS INFLATED TO 20 ATM AND BURST DUE TO THE CALCIUM. THE RX NC TAKERU WAS WEDGED INTO THE CALCIUM VALVE AND WHEN THE PHYSICIAN PULLED BACK TO REMOVE THE BALLOON, THE BALLOON SPLIT AND PARTIAL OF IT WAS LEFT BEHIND. THE PHYSICIAN THEN WAS ABLE TO PASS A ROTABLATOR (BOSTON SCIENTIFIC) 1.5 BURR PASS THE LESION AND BROKE UP THE BALLOON PIECE THAT WAS LEFT BEHIND. HE DID NOT TRY TO REMOVE THE PIECES AND LEFT IT IN THE PATIENT AND HAS NO CONCERN WITH IT. HE STATED THAT THE PIECES ARE SUBINTIMAL AND IS NOT CONCERNED TO HAVE THE PIECES THERE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 8352648 ↗