Ultraverse® 018 U8130630Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741064654), received between Oct 21, 2020 and Dec 3, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 018 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702607 ↗
• MalfunctionNov 20, 2025Break; Break

  ON (B)(6) 2025, PRIOR TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 018 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601889 ↗
• MalfunctionMar 31, 2025Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY GOT STUCK AND UNABLE TO TRACK TO THE DESIRED LOCATION FOR INFLATION. IT WAS FURTHER REPORTED THAT THERE WAS AN ISSUE WHEN TRYING TO READVANCE THE SHEATH. REPORTEDLY, IT WAS VERY TIGHT WHILE REMOVING THE DEVICE THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729325 ↗
• MalfunctionOct 1, 2024Burst Container or Vessel; Material Puncture/Hole; Material Split, Cut or Torn; Burst Container or Vessel; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER ALLEGEDLY HAD A HOLE IN IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343465 ↗
• InjuryJul 13, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AND DETACHED. IT WAS FURTHER REPORTED THAT PATIENT UNDERGONE A SURGERY TO REMOVE SOME PARTS OF THE BALLOON. PATIENT IS FINE AFTER SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12156298 ↗
• MalfunctionOct 26, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U8130630 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE (B)(6) YEAR OLD MALE WEIGHS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734781 ↗
• InjuryOct 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH COMMON FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE AT 4 ATM. HOWEVER, THE STENT DISSECTED AREA TO RESOLVE. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 10709816 ↗
• InjuryOct 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH COMMON FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. HOWEVER PERFORATION OF THE POPLITEAL VESSEL WAS RESOLVED WITH BALLOON TAMPONADE. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 10709732 ↗