Ultraverse® 035 PTA Dilatation Catheter U357554Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741092459), received between Jun 14, 2016 and Nov 25, 2025 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (15 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Deflation Problem; Leak/Splash; Difficult to Remove; Deflation Problem; Leak/Splash; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 035 PTA BALLOON, DURING THE PROCEDURE THE CATHETER HUB JOINT ALLEGEDLY LEAKED AND FURTHER IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO FULLY DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641927 ↗
• MalfunctionSep 24, 2025Inflation Problem; Material Rupture; Material Deformation; Inflation Problem; Material Rupture; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23130508 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST ANGIOPLASTY, PATIENT ALLEGEDLY EXPERIENCED STENOSIS AT THE SITE OF VENOTOMY. THE PATIENT HAS BEEN RECALLED FOR ANOTHER PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 16293229 ↗
• InjuryJan 13, 2023Difficult 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, BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE DISTAL HALF OF THE BALLOON GOT RETAINED BY THE SHEATH IN THE VEIN AND REMOVED WITH THE SHEATH AS ONE UNIT. REPORTEDLY, RUPTURED BALLOON DID NOT COME OUT SMOOTHLY THROUGH THE INTRODUCER SHEATH. THE PATIENT EXPERIENCED VESSEL TRAUMA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 16155556 ↗
• InjuryJun 30, 2022Break; Material Rupture; Detachment of Device or Device Component; Break; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANSLUMINAL ARTERIAL ANGIOPLASTY PROCEDURE OF ARTERIOVENOUS FISTULA, THE STRUCTURE OF THE BALLOON WAS ALLEGEDLY BROKEN DURING ITS WITHDRAWAL. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED BY OPEN SURGERY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 14869429 ↗
• MalfunctionMar 25, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, LEAK OCCURRED AT THE PROXIMAL HUB, WHERE THE CATHETER MEETS THE Y-CONNECTOR UPON INFLATING THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13903587 ↗
• MalfunctionAug 20, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AND TIP OF THE BALLOON SHEARED OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346780 ↗
• MalfunctionApr 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT THERE WAS A HOLE ON THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640325 ↗
• MalfunctionDec 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. 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 10956778 ↗
• MalfunctionOct 26, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THE MODEL U357554 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, GENDER AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738144 ↗
• MalfunctionOct 26, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U357554 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738114 ↗
• MalfunctionJan 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U357554 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE BALLOON MATERIAL RUPTURE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. THE PATIENT WAS A MALE; HOWEVER, THE AGE AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9598188 ↗
• MalfunctionJul 22, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO (2) MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U357554 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. EACH MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENTS' AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812542 ↗
• MalfunctionAug 15, 2018Break; Retraction Problem; Material Rupture; Detachment of Device or Device Component; Break; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LEFT UPPER ARM BRACHIOCEPHALIC FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED AT 17ATM. IT WAS FURTHER REPORTED THAT THE BALLOON PARTIALLY DETACHED FROM THE CATHETER SHAFT. THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT OVER THE GUIDEWIRE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785842 ↗
• InjuryDec 6, 2017Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ANGIOPLASTY OF A VENUS STENOSIS, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY. IT WAS FURTHER REPORTED THAT UPON RETRACTION THROUGH THE 7FR SHEATH, IT WAS IDENTIFIED THAT A SEGMENT OF THE BALLOON DETACHED AND REMAINED IN THE PATIENT. THE HEALTH CARE PROVIDER DECIDED TO CONCLUDE TREATMENT AND SCHEDULE A RETRIEVAL PROCEDURE IN THE OPERATING ROOM ON THE SAME DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7089163 ↗
• MalfunctionOct 9, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON OPENING THE INNER PACKAGING AN ALLEGED BREAK OCCURRED AT THE MIDDLE OF THE CATHETER SHAFT. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6931734 ↗
• InjurySep 18, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A JUXTA ANASTOMOTIC SEGMENT OF THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY UNDER THE RATED BURST PRESSURE ON THE FIRST INFLATION. THE HEALTH CARE PROVIDER REMOVED THE BALLOON AND CATHETER IN ITS ENTIRETY THROUGH THE SHEATH WITHOUT DIFFICULTY. THE PATIENT WAS SENT TO THE OR WHERE THE DETACHED BALLOON FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6874652 ↗
• MalfunctionAug 9, 2017Break; Aspiration Issue; Break; Aspiration Issue

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY, THE HEALTH CARE PROVIDER WAS ALLEGEDLY UNABLE TO ASPIRATE THE AIR FROM THE PTA BALLOON CATHETER. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6777969 ↗
• MalfunctionJun 13, 2017Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HEAVILY CALCIFIED LESION IN THE SFA THE PTA BALLOON ALLEGEDLY RUPTURED. AFTER THE RUPTURE OCCURRED THE DISTAL PORTION OF THE BALLOON CIRCUMFERENTIALLY DETACHED INSIDE THE PATIENT. REPORTEDLY, AS THE ORIGINAL GUIDEWIRE WAS BEING REMOVED FROM THE PATIENT, THE DISTAL PORTION OF THE BALLOON WAS ATTACHED TO THE GUIDEWIRE AND WAS ABLE TO BE REMOVED SUCCESSFULLY. THE HEALTH CARE PROVIDER WAS ABLE TO SUCCESSFULLY DEPLOY A STENT AT THE LESION SITE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6638685 ↗
• MalfunctionMar 22, 2017Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO ADVANCE OVER THE GUIDE WIRE. THE 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 6425814 ↗
• MalfunctionFeb 3, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AN ALLEGED LEAK WAS OBSERVED AT THE STRAIN RELIEF OF THE DEVICE POST INFLATION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301533 ↗
• MalfunctionOct 24, 2016Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON DILATATION CATHETER ALLEGEDLY WOULD NOT THREAD ONTO THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE PTA BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6052884 ↗
• MalfunctionJun 14, 2016Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA ALLEGEDLY RUPTURED AT 18 ATM. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) HAD DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH. REPORTEDLY, THE HCP HAD TO ENLARGE THE ACCESS SITE IN ORDER TO REMOVE THE BALLOON AND SHEATH TOGETHER AS ONE UNIT. NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5723466 ↗