Ultraverse® 035 PTA Dilatation Catheter U357564Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741092954), received between Feb 21, 2017 and Dec 18, 2025 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, PRIOR TO A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. IT WAS FOUND PRIOR TO THE PROCEDURE; BALLOON ALLEGEDLY SHAFT CUTTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835893 ↗
• MalfunctionSep 25, 2025Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23142887 ↗
• MalfunctionAug 20, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING ULTRAVERSE 035 AND IT WAS REPORTED THAT DURING THE PROCEDURE THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847329 ↗
• MalfunctionAug 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PACKAGING OF ULTRAVERSE 035 PTA BALLOON ALLEGEDLY GOT CONTAMINATED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825023 ↗
• InjuryJul 23, 2025Entrapment of Device; Material Rupture; Detachment of Device or Device Component; Entrapment of Device; Material Rupture; Detachment of Device or Device Component

  ON (B)(6) 2025 A PATIENT UNDERWENT THE BALLOON ANGIOPLASTY PROCEDURE IN COMMON ILIAC ARTERY USING THE ULTRA VERSE BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE THE BALLOON WAS ALLEGEDLY BROKEN INTO TWO PIECES. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED FROM NP TO RBP AT ILIAC ARTERY FOR LESS THAN 30 SECS. REPORTEDLY THE BALLOON SEGMENT WAS STUCK IN THE PATIENT BLOOD VESSEL. THE PATIENT'S VESSEL WAS CUT TO TAKE THE BALLOON OUT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22574047 ↗
• MalfunctionMay 5, 2025Break; Break

  ON (B)(6) 2025, THE PATIENT UNDERWENT FOR AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 035. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PTA CATHETER SHAFT WAS ALLEGEDLY FOUND TO BE BROKEN AND THE PACKAGING INTACT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958755 ↗
• MalfunctionMar 26, 2025Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694891 ↗
• MalfunctionFeb 19, 2025Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 4 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417638 ↗
• MalfunctionJan 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THERE WAS A HAIR PROTRUDING FROM THE HOUSING SHEATH BETWEEN THE SHEATH AND THE BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206715 ↗
• MalfunctionJul 25, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824729 ↗
• MalfunctionJul 8, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE STENOSED LEFT COMMON ILIAC ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 10 ATM DURING THE FIRST INFLATION. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY A LITTLE RESISTANCE WHILE RETRIEVING THE BALLOON THROUGH THE SHEATH. FURTHERMORE, AFTER MULTIPLE ATTEMPTS, IT WAS RETRIEVED AS A WHOLE WITHOUT REMOVAL OF THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687830 ↗
• MalfunctionMay 30, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19432420 ↗
• MalfunctionMay 29, 2024Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE ARTERIAL ANASTOMOSIS, THE PTA BALLOON ALLEGEDLY RUPTURED AT 16 ATM AND BROKE IN HALF. IT WAS FURTHER REPORTED THAT THE TIP OF THE BALLOON WAS COMPLETELY DETACHED AND WHILE TRYING TO TAKE THE BALLOON OUT OF THE SHEATH, THE BALLOON WOULD NOT COME OUT AND THE TIP WAS ALLEGEDLY LODGED IN THE PATIENT'S ARM. REPORTEDLY, THE WHOLE SHEATH WITH THE BALLOON INSIDE WAS REMOVED AND THE SHEATH WAS PLACED AGAIN, AND THE DETACHED COMPONENT WAS COMPLETELY RETRIEVED USING A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19412749 ↗
• MalfunctionJan 23, 2023Break; Leak/Splash; Material Puncture/Hole; Break; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT ALLEGEDLY HAD HOLES. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY LEAKING AIR AND CONTRAST. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223859 ↗
• MalfunctionDec 14, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY LEAKED CONTRAST UPON INFLATION AT 12 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED AND RE-INFLATED, SAME THING ALLEGEDLY HAPPENED. REPORTEDLY, THE BALLOON WAS REMOVED AND RINSED OFF AND IT WAS INFLATED ONCE AGAIN AND BALLOON ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977493 ↗
• MalfunctionNov 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED UPON INFLATION. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD A HOLE AT THE END. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884447 ↗
• MalfunctionNov 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA AN ANTEGRADE FEMORAL APPROACH, THE PTA BALLOON CATHETER ALLEGEDLY DETACHED INTO TWO PIECES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12873527 ↗
• MalfunctionNov 11, 2021Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY TORE OFF THE CATHETER DURING RETRACTION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12792175 ↗
• MalfunctionOct 18, 2021Deflation Problem; Difficult to Insert; Device-Device Incompatibility; Deflation Problem; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY BEING DEFLATED AND FAILED TO BE INSERTED AT THE SECOND ATTEMPT. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12645719 ↗
• MalfunctionSep 9, 2021Deflation Problem; Difficult to Insert; Device-Device Incompatibility; Deflation Problem; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY BEING DEFLATED AND FAILED TO BE INSERTED THROUGH THE SHEATH AT THE SECOND ATTEMPT. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445058 ↗
• MalfunctionMar 5, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE THROUGH THE CEPHALIC VEIN TO TREAT CIRCUIT STENOSIS, THE TIP OF THE BALLOON ALLEGEDLY SEPARATED FROM THE DEVICE. THE SEPARATED TIP WAS SNARED AND RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419371 ↗
• MalfunctionApr 15, 2020Material Rupture; Material Rupture

  THIS INFORMATION SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL U357564, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9964570 ↗
• InjuryAug 8, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT COMMON ILIAC, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY STUCK AND DETACHED FROM THE CATHETER UPON REMOVAL. REPORTEDLY, MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE DETACHED SEGMENT FROM THE PATIENT WITHIN A DIFFERENT ACCESS SITE USING A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTEDLY DISCHARGE POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8876190 ↗
• MalfunctionJul 22, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT THE CATHETER SHAFT OF A MODEL U357564 PTA BALLOON DILATATION CATHETER ALLEGEDLY BROKE AND DETACHED. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8811846 ↗
• MalfunctionApr 16, 2019Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL U357564 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED CIRCUMFERENTIALLY. THESE REPORT WAS RECEIVED FROM ONE SOURCE. OF THE ONE EVENT, DID INVOLVED PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS' AGE RANGED FROM 74 YEARS, WEIGHT WAS 161 LBS. OF THE REPORTED PATIENTS, ONE WAS MALE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8518817 ↗