Ultraverse® 035 PTA Dilatation Catheter U3575104Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741094583), received between Nov 16, 2016 and Jun 9, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 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 BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165366 ↗
• MalfunctionMay 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE ULTRAVERSE 035 PTA BALLOON WAS ALLEGEDLY RUPTURED AT 4 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949179 ↗
• MalfunctionJul 10, 2024Material 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 19708107 ↗
• MalfunctionJul 10, 2023Burst Container or Vessel; Material Split, Cut or Torn; Burst Container or Vessel; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285058 ↗
• MalfunctionOct 6, 2022Difficult 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 IN THE RIGHT COMMON ILIAC ARTERY, THE PTA BALLOON ALLEGEDLY UNABLE TO BE ADVANCED AND DIFFICULT TO BE REMOVED FROM THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED ALONG WITH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550103 ↗
• MalfunctionDec 9, 2021Difficult to Remove; Material Separation; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Material Separation; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT FIT THROUGH A SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967141 ↗
• MalfunctionAug 8, 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 IN THE COMMON ILIAC ARTERY VIA IPSILATERAL RETROGRADE APPROACH, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO INSERT THROUGH THE SHEATH. THEREFORE NEGATIVE PRESSURE WAS APPLIED AND THE DEVICE WAS INSERTED SLOWLY . IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY STUCK INSIDE THE SHEATH AND THE BALLOON AND SHEATH WERE REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292196 ↗
• InjuryAug 4, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST ANGIOPLASTY PROCEDURE TO TREAT A VERY TIGHT STENOSIS IN THE AXILLARY VEIN, THE BALLOON ALLEGEDLY RUPTURED AND TORE APART DURING REMOVAL OF DEVICE FROM THE PATIENT. IT WAS FURTHER REPORTED THAT EVEN AFTER MULTIPLE ATTEMPTS TO RECOVER THE TORN DEVICE, A SMALL PIECE OF THE BALLOON WAS LEFT BEHIND AND WAS UNRECOVERABLE. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12273440 ↗
• MalfunctionMar 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING STENOSIS IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 5ATM. 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 11559263 ↗
• MalfunctionJun 19, 2017Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY GOT STUCK INSIDE THE 6FR SHEATH UPON REMOVAL FROM THE PATIENT. THE HEALTH CARE PROVIDER REMOVED THE SHEATH AND BALLOON TOGETHER AS ONE UNIT AND USED A NEW SHEATH AND BALLOON 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 6652558 ↗
• InjuryMay 4, 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 POST-DILATATION OF A BARE METAL STENT PLACED IN THE CEPHALIC ARCH, THE PTA BALLOON ALLEGEDLY RUPTURED (ATM UNKNOWN) DURING THE FIRST INFLATION. IT WAS FURTHER REPORTED THAT A MAJORITY OF THE BALLOON DETACHED AND REMAINED WITHIN THE STENT AND THE BALLOON CATHETER WAS DIFFICULT TO RETRACT THROUGH THE STENT AND THE SHEATH. REPORTEDLY, A STENT GRAFT WAS DEPLOYED TO APPOSE THE DETACHED BALLOON SEGMENT AGAINST THE STENT AND VESSEL WALL. ANOTHER BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6546071 ↗
• MalfunctionMar 4, 2017Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO INSERT THROUGH THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT AN ALLEGED KINK WAS IDENTIFIED. THE PTA BALLOON WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6378664 ↗
• MalfunctionFeb 9, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE THE STERILE PACKAGING ALLEGEDLY CONTAINED A PARTICLE INSIDE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6314084 ↗
• MalfunctionNov 16, 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 AT THE STRAIN RELIEF. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6107669 ↗