Ultraverse® 035 PTA Dilatation Catheter U3575610Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741092985), received between Jun 12, 2018 and Jul 15, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionJul 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747139 ↗
• MalfunctionJul 2, 2021Difficult 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 PTA BALLOON WAS ALLEGEDLY HAD DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105734 ↗
• MalfunctionJul 21, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT THE MODEL U3575610 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A FEMALE; HOWEVER, THE AGE AND WEIGHT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306188 ↗
• MalfunctionApr 20, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U3575610 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) MALE PATIENT IS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9977603 ↗
• InjuryAug 29, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT POPLITEAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED AND AN ATHERECTOMY WAS PERFORMED TO REMOVE THE CALCIFICATION.

  Patient problems: Injury

  MAUDE report 8946550 ↗
• InjuryDec 13, 2018Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY HAD ISSUES DEFLATING. A NEEDLE STICK WAS USED TO PUNCTURE AND DEFLATION THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 8162737 ↗
• MalfunctionJun 12, 2018Retraction Problem; Material Rupture; Material Deformation; Retraction Problem; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY BEING RETRACTED THROUGH THE SHEATH. THE MALFUNCTIONED DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7592347 ↗