Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-60150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391525786445), received between Feb 16, 2023 and Mar 15, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2023Fracture; Fracture

  THE BALLOON WAS USED IN THE PROXIMAL POPLITEAL - SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A PASS, THE BALLOON WAS DEFLATED. UPON REMOVAL, THE SURGEON NOTICED THE BALLOON CATHETER WAS OUTSIDE THE SHEATH. THE BALLOON CATHETER REPORTEDLY BROKE. THE SURGEON WAS ABLE TO RETRIEVE THE BALLOON IN THE DISTAL RAPID EXCHANGE PORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF A SECOND BALLOON. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THE EVENT PERTAINED TO A RADIAL PROCEDURE. DURING REMOVAL, THE SURGICAL TECHNICIAN CONFIRMED THE BALLOON WAS DEFLATED. NO RESISTANCE WAS MET. ONCE REMOVED FROM THE SHEATH, THE DISTAL SEGMENT REMAINED IN THE PATIENT. THE CATHETER SEPARATED AT THE RX PORT. IMAGING CONFIRMED THE BALLOON MARKER BANDS WERE OUTSIDE OF THE SHEATH. THE SURGEON WAS ABLE TO USE A SNARE AND RETRIEVE THE CATHETER SEGMENT WITHIN APPROXIMATELY FOUR MINUTES. NO ADDITIONAL INTERVENTIONS OR ACCESS POINTS WERE REQUIRED. THE ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY FOUR MINUTES. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16550059 ↗
• InjuryMar 15, 2023Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THE TARGET VESSEL WAS APPROXIMATELY 5-6MM. REGARDING THE REPORT OF "STICKY BALLOON", THERE WAS NO RESTRICTION WHEN UNSHEATHING THE BALLOON PROTECTOR. IT WAS NOTED THAT FORCE WAS REQUIRED TO CROSS THE LESION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16549971 ↗
• MalfunctionFeb 16, 2023Material Rupture; Material Separation; Material Rupture; Material Separation

  DURING THE PROCEDURE WHEN THE SURGEON WAS FINISHED WITH BALLOONING, RESISTANCE WAS MET WHEN REMOVING THE BALLOON THROUGH THE GUIDE SHEATH. THE SURGEON FELT THE BALLOON BURST AND SAW UNDER FLUOROSCOPY THAT THE BALLOON HAD BURST IN THE SHEATH. THE SURGEON THEN USED ANOTHER BALLOON TO PLUG THE END OF THE SHEATH TO TRAP THE REMAINING PIECES OF THE BALLOON IN THE SHEATH. THE SURGEON THEN PULLED EVERYTHING OUT. THERE WAS NO IMPACT TO PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THE SURGICAL TECHNICIAN USED THE SAME TECHNIQUE WHEN DEFLATING THE BALLOON AS USUAL. FLUOROSCOPY WAS ALSO PERFORMED TO CONFIRM DEFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16392120 ↗