Ultraverse® 014 U4150330Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741064463), received between Jan 14, 2020 and Nov 26, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656413 ↗
• MalfunctionSep 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 10ML SALINE FILL CHINA SP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, FOLLOWING COMPLETION OF INTRAVENOUS MEDICATION INFUSION, THE CENTRAL VENOUS CATHETER WAS ROUTINELY SEALED USING A PRE-FILLED CATHETER FLUSHING DEVICE. DURING THE INJECTION PROCESS, LEAKAGE OCCURRED AT THE PRE-FILLED PISTON. THE PRE-FILLED CATHETER FLUSHING DEVICE WAS IMMEDIATELY REPLACED FOR THE PATIENT, AND THE SEALING PROCEDURE WAS REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23091912 ↗
• MalfunctionOct 11, 2023Difficult to Remove; Difficult to Open or Remove Packaging Material; Difficult to Remove; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, WHILE LOADING THE PTA BALLOON ON THE WIRE, THE BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE SHEATH AND WAS STUCK INSIDE THE SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913120 ↗
• MalfunctionJun 6, 2022Material Rupture; Failure to Advance; Material Twisted/Bent; Material Rupture; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY UNABLE TO CROSS LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600024 ↗
• InjurySep 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE POPLITEAL ARTERY VIA COMMON FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. IT WAS FURTHER REPORTED THAT THE PERONEAL ARTERY PERFORATED. A BALLOON EXPANDABLE VASCULAR COVERED STENT WAS USED TO COMPLETE THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 10587339 ↗
• InjuryJun 30, 2020Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH TIBIAL ARTERY, THE PTA BALLOON ALLEGEDLY HAD A PINHOLE RUPTURED AT 4 ATM IN THE POSTERIOR TIBIAL (PT) ARTERY. IT WAS FURTHER REPORTED THAT THE TREATMENT PLAN CHANGED TO AT/PEDAL LOOP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Perforation; Vascular Dissection

  MAUDE report 10211107 ↗
• MalfunctionJan 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150330 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCE DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587427 ↗