Ultraverse® 035 PTA Dilatation Catheter U35130630Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741093258), received between Nov 10, 2016 and Jun 13, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY GOT STUCK WITHIN THE SHEATH WHEN DEFLATED TO PULL OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115949 ↗
• MalfunctionApr 13, 2023Break; Inflation Problem; Material Twisted/Bent; Break; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY THROUGH CONTRALATERAL APPROACH, THE PTA BALLOON WAS SEEMED TO BE ALLEGEDLY TWISTED WHILE IN PATIENT. IT WAS FURTHER REPORTED THAT WHILE INFLATING TO NOMINAL PRESSURE, THERE WAS ONE CENTIMETER SEGMENT WHICH WAS NOT DILATED. REPORTEDLY, THE BALLOON WAS RE POSITIONED TO POST DILATE THE SEGMENT THAT WAS NOTICED AS NOT DILATED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730482 ↗
• MalfunctionOct 26, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U35130630 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD MALE PATIENT WAS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737883 ↗
• MalfunctionJul 22, 2020Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U35130630 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE FEMALE PATIENT WAS (B)(6) AND WEIGHT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10309817 ↗
• MalfunctionJun 19, 2018Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SFA USING AN ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY GOT STUCK INSIDE THE 6FR SHEATH AND SUBSEQUENTLY COULD NOT BE RETRACTED. THE BALLOON AND SHEATH WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7617463 ↗
• MalfunctionMay 29, 2018Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY WAS UNABLE TO DEFLATE AND SUBSEQUENTLY WAS DIFFICULT TO REMOVE THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7551429 ↗
• MalfunctionNov 10, 2016Break; Leak/Splash; Retraction Problem; Break; Leak/Splash; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SFA, A LEAK WAS ALLEGEDLY IDENTIFIED NEAR THE HUB. REPORTEDLY, DIFFICULTY WAS ENCOUNTERED DURING RETRACTION OF THE DEVICE; THEREFORE, A SYRINGE WAS USED TO REMOVE THE CONTRAST AND SALINE FROM THE BALLOON TO AIDE IN THE RETRACTION FROM THE SHEATH. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6093705 ↗