Regalia XS 1.0 PAGP140300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547327088312), received between Feb 21, 2019 and May 29, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• InjuryMay 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED LESION IN THE PEDAL LOOP. WHEN AN ASAHI REGALIA XS 1.0 GUIDE WIRE WAS ADVANCED WITH THE SUPPORT OF A PHILIPS QUICK-CROSS SUPPORT CATHETER IN THE PEDAL LOOP, IT GOT STUCK AND BROKE APART DURING WIRE REMOVAL. ABOUT 30MM OF THE GUIDE WIRE WAS LEFT IN THE PATIENT'S LEG. THE PHYSICIAN DECIDED TO MAKE NO ATTEMPT TO REMOVE THE WIRE FRAGMENT DUE TO THE VESSEL SIZE. THE WIRE FRAGMENT WAS PUSHED AGAINST THE VESSEL WALL BY BALLOONING. THE INTENDED TREATMENT WAS COMPLETED WITHOUT ANY ISSUE. IT WAS INFORMED THAT THE PATIENT WAS FINE AND DISCHARGED AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22103228 ↗
• MalfunctionMay 14, 2025Break; Break

  PHYSICAN WAS WORKING ON THE PEDAL LOOP WITH A QUICKCROSS AND REGAILIA XS WIRE. WIRE GOT STUCK AND BROKE APART WHEN REMOVING THE WIRE. 30MM OF THE WIRE WAS LEFT IN THE PATIENT'S LEG. THE PROCEDURE ENDED WITH THE PHYSICIANS BALLOONING THE WIRE IN THE VESSEL. NO ATTEMPT WAS MADE TO REMOVE DUE TO THE CALIBER SIZE OF THE VESSEL. THE PATIENT WAS FINE AND DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22020904 ↗
• InjurySep 11, 2019Break; Break

  IT WAS REPORTED THAT THE COATING AT THE END OF AN ASAHI REGALIA XS 1.0 GUIDE WIRE WAS SHREDDED AFTER ENTERING THE POPLITEAL ARTERY DURING A PPI TO TREAT A CALCIFIED LESION IN THE LOWER EXTREMITY. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9000564 ↗
• MalfunctionAug 23, 2019Material Split, Cut or Torn

  THE COATING AT THE END WAS SHREDDED AFTER ENTERING THE POPLITEAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8924125 ↗
• InjuryFeb 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RADIOPAQUE TIP OF THE GUIDE WIRE WAS DETACHED FROM THE WIRE UPON REMOVAL INTO THE SHEATH DURING A PPI TO TREAT A CTO IN THE ANTERIOR TIBIAL ARTERY. THE PHYSICIAN SNARED THE TIP AND PULLED INTO THE SHEATH. WHILE REMOVING THE SHEATH, THE TIP WAS LOST IN THE CUTANEOUS PART OF THE PATIENT BODY BUT OUT OF THE VESSEL. THE PHYSICIAN CONTINUED TO WORK ON THE CTO AND OPENED UP THE LESION. AFTER THIS WAS DONE HE PERCLOSED THE VESSEL AND LEFT THE TIP WHERE IT WAS. ANOTHER VASCULAR SURGEON WILL REMOVE THE REMAINING TIP WHEN THE PATIENT RETURNS FOR A FOLLOW-UP PROCEDURE IN NEXT FEW DAYS.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8360573 ↗