Ultraverse® 035 PTA Dilatation Catheter U3513084Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741094170), received between May 1, 2017 and Jun 18, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 PTA BALLOON CATHETER. DURING THE PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 7ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282216 ↗
• MalfunctionNov 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN RIGHT COMMON ILIAC ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672693 ↗
• MalfunctionAug 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE RUPTURED AT THE RATED BURST PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17648988 ↗
• MalfunctionOct 26, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY HAD INFLATION ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672749 ↗
• MalfunctionOct 10, 2022Break; Burst Container or Vessel; Difficult to Insert; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Burst Container or Vessel; Difficult to Insert; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT COMMON FEMORAL, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE INSERTED THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AND HAD DIFFICULTY IN RETRACTING THROUGH THE INTRODUCER SHEATH AND EVENTUALLY THE CATHETER BROKE OFF WITHIN THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AS SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574057 ↗
• MalfunctionAug 31, 2021Burst Container or Vessel; Difficult to Insert; Material Rupture; Device-Device Incompatibility; Burst Container or Vessel; Difficult to Insert; Material Rupture; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD FAULT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12390631 ↗
• MalfunctionNov 30, 2020Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10918056 ↗
• MalfunctionOct 27, 2020Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U3513084 PTA BALLOON DILATATION CATHETER ALLEGEDLY RETRACTION ISSUE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10744368 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL U3513084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965005 ↗
• InjuryApr 2, 2018Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING AN ANGIOPLASTY PROCEDURE IN A A/V FISTULA, THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED PAST RATED BURST PRESSURE. REPORTEDLY, THE PTA BALLOON ALLEGEDLY BECAME STUCK INSIDE THE 6FR SHEATH DURING RETRACTION. IT WAS FURTHER REPORTED THAT WHEN THE BALLOON AND SHEATH WERE REMOVED FROM THE PATIENT, A SEGMENT OF THE BALLOON MATERIAL ALLEGEDLY DETACHED. THE PATIENT WAS SENT TO SURGERY FOR REMOVAL OF THE DETACHED BALLOON SEGMENT. THE PATIENT WAS REPORTED TO BE DOING WELL POST SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7390848 ↗
• MalfunctionFeb 15, 2018Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER A SUCCESSFUL ANGIOPLASTY PROCEDURE THE PTA BALLOON CATHETER ALLEGEDLY GOT STUCK INSIDE THE 5FR SHEATH AND SUBSEQUENTLY THE BIFURCATION DETACHED FROM THE CATHETER SHAFT. REPORTEDLY, THE REMAINING CATHETER WAS PULLED OUT FROM THE SHEATH AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7273774 ↗
• MalfunctionMay 1, 2017Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT RENAL ARTERY THE PTA BALLOON ALLEGEDLY RUPTURED CAUSING THE TIP OF THE BALLOON TO DETACH INSIDE THE SHEATH UPON REMOVAL FROM THE PATIENT. REPORTEDLY, THE HEALTH CARE PROVIDER (HCP) FOUND THAT THE TIP OF THE BALLOON AND RADIOPAQUE MARKER WAS MISSING. UPON FURTHER EXAMINATION THE HCP WAS ABLE TO REMOVE THE RADIOPAQUE MARKER. HOWEVER, IT WAS DECIDED BY THE HCP NOT REMOVE THE BALLOON TIP DESPITE MULTIPLE ATTEMPTS. 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 6535849 ↗