Ultraverse® 035 PTA Dilatation Catheter U357574Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741093456), received between Oct 24, 2016 and May 14, 2025 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Material Puncture/Hole; Material Puncture/Hole

  ON (B)(6) 2025, A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 035. DURING THE PROCEDURE, THE PTA BALLOON WAS INSERTED INTO THE SHEATH AND INTO THE PATIENT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS FAILED TO INFLATE AND NOTED THAT THERE WAS A HOLE IN THE CATHETER SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015820 ↗
• MalfunctionJan 20, 2025Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21189222 ↗
• MalfunctionSep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE HIGHLY CALCIFIED LESION VIA AN IPSILATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20298316 ↗
• MalfunctionApr 24, 2024Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A TINY HOLE IN THE SHAFT OF THE BALLOON. IT WAS FURTHER REPORTED THAT THE PTA BALLOON ALLEGEDLY LEAKED DURING FLUSHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169933 ↗
• MalfunctionNov 29, 2023Material 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 18226339 ↗
• MalfunctionMar 20, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16578930 ↗
• MalfunctionFeb 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6 ATM UPON INFLATION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324305 ↗
• MalfunctionDec 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON 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 15892084 ↗
• MalfunctionJul 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA RIGHT UPPER ARM, THE PTA BALLOON ALLEGEDLY LEAKED THE CONTRAST AGENT. 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 15073302 ↗
• MalfunctionFeb 11, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE RUPTURED BALLOON ALLEGEDLY CAUSING BLOCKAGE IN THE INTRODUCER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13512364 ↗
• InjuryMay 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT DUE TO RUPTURE CAUSING A REFLUX OF THROMBUS INTO THE PATIENT'S ARTERY AND THE THROMBUS EMBOLIZED DOWN THE ARTERY TOWARDS THE PATIENT'S HAND, CAUSING AN OCCLUSION. THE PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 11804233 ↗
• MalfunctionApr 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A BALLOON RUPTURE. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730347 ↗
• MalfunctionMar 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD FOREIGN MATERIAL INSIDE THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11432044 ↗
• MalfunctionOct 26, 2020Break; Material Rupture; Device Dislodged or Dislocated; Break; Material Rupture; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U357574 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE, DEVICE DISLODGED OR DISLOCATED, MATERIAL DEFORMATION AND BREAK. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6) YEARS OLD FEMALE PATIENT WEIGHS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738180 ↗
• MalfunctionJul 22, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U357574 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM VARIOUS SOURCE. TWO PATIENTS INVOLVED WITH NO REPORTED PATIENT INJURY. ONE PATIENT WAS FEMALE, REMAINING PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10309801 ↗
• MalfunctionJul 24, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U357574 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTION INVOLVED PATIENTS WITHOUT CONSEQUENCE. ONE PATIENT WAS REPORTED TO BE MALE; ALL OTHER AGE, WEIGHT, AND SEX INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823307 ↗
• MalfunctionJul 24, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U357574 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A 63 YEAR-OLD WHOSE GENDER AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823128 ↗
• MalfunctionOct 13, 2017Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A TIGHT STENOSIS IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED BETWEEN 10 AND 11 ATM ON THE FIRST INFLATION. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER HAD DIFFICULTY RETRACTING THE BALLOON THROUGH THE 7FR SHEATH. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6949109 ↗
• MalfunctionAug 24, 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 OF AN UPPER ARM FISTULA, AN ALLEGED PINHOLE RUPTURE OCCURRED AND WAS SUBSEQUENTLY DIFFICULT TO RETRACT THROUGH THE 7FR SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT THROUGH A LARGER SHEATH. THE HEALTH CARE PROVIDER SUTURED THE ACCESS SITE AND APPLIED PRESSURE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6818243 ↗
• MalfunctionJun 26, 2017Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LEFT ARM FISTULA PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY AT 24 ATM DURING THE FIRST INFLATION. THE HEALTH CARE PROVIDER(HCP) WAS ABLE TO RETRIEVE THE BALLOON CATHETER AND BALLOON SEGMENTS SUCCESSFULLY THROUGH THE SHEATH. REPORTEDLY, THE HCP SUCCESSFULLY DEPLOYED A STENT AT THE LESION SITE TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6667330 ↗
• MalfunctionJun 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A VENOUS ANASTOMOSIS, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY UPON REACHING 12ATM. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6657991 ↗
• MalfunctionJun 6, 2017Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AN ALLEGED LEAK WAS FOUND AT THE INFLATION HUB OF THE BALLOON. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6617087 ↗
• MalfunctionDec 8, 2016Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BASILIC VEIN THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY AT 20 ATM DURING THE FIRST INFLATION. REPORTEDLY, THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE 6FR SHEATH. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6156518 ↗
• MalfunctionOct 24, 2016Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING THE FIRST INFLATION, THE PTA BALLOON CATHETER ALLEGEDLY LEAKED AT THE HUB. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6052846 ↗
• MalfunctionOct 24, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE MAIN CATHETER. REPORTEDLY, THE HEALTH CARE PROVIDER WAS ABLE TO RETRIEVE THE DETACHED SEGMENT FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED RETRACTION DIFFICULTIES. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6051518 ↗