Ultraverse® 035 PTA Dilatation Catheter U3513066Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741093180), received between Jan 3, 2017 and Oct 14, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT DURING PRE-DILATATION OF THE LEFT LEG NON-TARGET LESION STENOSIS ON THE PROXIMAL SUPERFICIAL FEMORAL ARTERY USING THE BALLOON CATHETER, THE SUBJECT HAD AN ADVERSE EVENT OF DISSECTION. REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT CAUSAL RELATIONSHIP TO THE STUDY PROCEDURE. REPORTEDLY, THE ADVERSE EVENT WAS TREATED WITH STENT PLACEMENT AND THE OUTCOME WAS RECOVERED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 20437000 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST AN ANGIOPLASTY PROCEDURE, THE PATIENT ALLEGEDLY HAD NO PULSATION AND LOW SKIN TEMPERATURE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED MASSIVE THROMBOSIS IN THE ARTERIES OF THE LEFT LOWER EXTREMITY AND AN EMERGENCY ARTERIOTOMY AND EXPLORATORY THROMBECTOMY OF THE LEFT LOWER EXTREMITY ARTERIES WAS PERFORMED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 18423707 ↗
• InjuryMay 25, 2023Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER ALLEGEDLY HAD A KINK. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE ALLEGEDLY FAILED TO ADVANCE THROUGH THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001145 ↗
• MalfunctionOct 28, 2022Break; Failure to Advance; Device-Device Incompatibility; Material Deformation; Break; Failure to Advance; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE VIA FISTULA THROUGH RIGHT FEMORAL ARTERY, THE GUIDE WIRE ALLEGEDLY FAILED TO ADVANCE THROUGH THE LUMEN OF THE DEVICE CATHETER. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY BROKEN AND KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690585 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334951 ↗
• MalfunctionJan 3, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE IN THE LEFT SFA THE BALLOON CATHETER ALLEGEDLY DETACHED FROM THE INFLATION HUB UPON REMOVING THE BALLOON FROM THE PROTECTIVE SLEEVE. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6220109 ↗