CONFIANZA PRO 12 AGH143091Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547327058155), received between May 13, 2021 and May 19, 2025 — classified as 2 injuries, 1 malfunction.

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.

• InjuryMay 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CONFIANZA PRO 12 GUIDE WIRE HAD FRACTURED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN AN UNSPECIFIED VESSEL. THE PHYSICIAN DETERMINED TO TAKE NO ADDITIONAL ACTION AGAINST THIS EVENT AND LEAVE THE WIRE FRAGMENT IN SITU. IT WAS INFORMED THAT THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22042278 ↗
• InjuryJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CONFIANZA PRO 12 GUIDE WIRE DETACHED DURING A RETROGRADE PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY (RCA). THE GUIDE WIRE WAS ADVANCED RETROGRADE FROM THE LEFT ANTERIOR DESCENDING ARTERY (LAD) INTO THE RCA IN ATTEMPTS TO BREAK THROUGH THE OCCLUSION. THE DECISION TO EXCHANGE WIRES WAS MADE AND UPON TRYING TO PULL BACK THE WIRE IT APPEARED TO BE "STUCK". AFTER SOME THOUGHT AND A SECOND DOCTORS CONSULT THERE WAS NOTHING TO DO OTHER THEN PULL IT BACK. THE WIRE UNRAVELED AND BROKE APART LEAVING THE DISTAL TIP OF THE WIRE IN THE RCA AND SOME OF THE UNRAVELED WIRE ALL THE WAY BACK THROUGH INTO THE LEFT SYSTEM. THE PHYSICIAN STENTED THE LEFT MAIN AND LAD PINCHING THE WIRE BETWEEN THE VESSEL AND THE STENT SO THAT IT WOULD NOT GO ANYWHERE. THE PATIENT WAS ADMITTED OVERNIGHT WITH CLOSE MONITORING AND WAS DISCHARGED IN STABLE CONDITION THE FOLLOWING DAY AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11918548 ↗
• MalfunctionMay 13, 2021Break; Unraveled Material; Obstruction of Flow

  NARRATIVE FROM STAFF: WHILE PERFORMING A CTO PCI (CHRONIC TOTAL OCCLUSION) IN THE CATH LAB AN INTERVENTIONAL WIRE WAS ADVANCED (CP12) RETROGRADE FROM THE LAD {LEFT ANTERIOR DESCENDING ARTERY) INTO THE RCA (RIGHT CORONARY ARTERY) AND ATTEMPTED TO BREAK THROUGH THE OCCLUSION. THE DECISION TO EXCHANGE WIRES WAS MADE AND UPON TRYING TO PULL BACK THE WIRE IT APPEARED TO BE "STUCK". AFTER SOME THOUGHT AND A SECOND DOCTORS CONSULT THERE WAS NOTHING TO DO OTHER THEN PULL IT BACK. THE WIRE UNRAVELED AND BROKE APART LEAVING THE DISTAL TIP OF THE WIRE IN THE RCA AND SOME OF THE UNRAVELED WIRE ALL THE WAY BACK THROUGH INTO THE LEFT SYSTEM. WE STENTED THE LEFT MAIN AND LAD PINCHING THE WIRE BETWEEN THE VESSEL AND THE STENT SO THAT IT WOULD NOT GO ANYWHERE. OTHER EQUIPMENT IN THE BODY AT THE TIME WAS A 7F EBU 4.0 AND A 150MM CARAVEL MICROCATHETER.

  Patient problems: Insufficient Information

  MAUDE report 11823297 ↗