Ultraverse® 014 U4150222Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741053474), received between Nov 16, 2018 and Mar 31, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2021Break; Failure to Advance; Detachment of Device or Device Component; Break; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A 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 11594089 ↗
• MalfunctionAug 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE POST TIBIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED CIRCUMFERENTIALLY AT 22ATM. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10371809 ↗
• MalfunctionJul 22, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U4150222 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK .THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10306527 ↗
• MalfunctionApr 15, 2020Break; Packaging Problem; Break; Packaging Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL U4150222 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED PACKAGING PROBLEM AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED (B)(6) PATIENT WITH NO REPORTED CONSEQUENCES. NO OTHER PATIENT INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963897 ↗
• MalfunctionJul 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U4150222 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8809453 ↗
• MalfunctionApr 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL U4150222 PTA BALLOON DILATATION CATHETER ALLEGEDLY DETACHED. THESE REPORT WAS RECEIVED FROM ONE SOURCE. OF THE ONE EVENT, DID NOT INVOLVED PATIENT WITH NO REPORTED PATIENT CONTACT. THE PATIENTS' AGE RANGED FROM 64 YEARS, WEIGHT WAS 63 KGS. OF THE REPORTED PATIENTS, ONE WAS FEMALE.

  Patient problems: No Patient Involvement

  MAUDE report 8519698 ↗
• MalfunctionJan 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON REMOVAL OF THE PROTECTIVE SLEEVE, THE PTA BALLOON ALLEGEDLY DETACHED. ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8261799 ↗
• MalfunctionNov 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8091245 ↗
• MalfunctionNov 16, 2018Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR A PTA PROCEDURE, THE CATHETER ALLEGEDLY BROKE PROXIMAL TO THE BALLOON WHILE REMOVING THE BALLOON GUARD AND STYLET. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8078289 ↗