Ultraverse® RX U4200220RXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741056338), received between Apr 11, 2018 and Sep 6, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2019Break; Failure to Advance; Detachment of Device or Device Component; Break; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT POSTERIOR TIBIAL ARTERY, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTLY CROSSING THE LESION. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE UPON COMPLETION OF THE ANGIOPLASTY PROCEDURE, SEGMENTS OF THE BALLOON AND CATHETER REMAINED IN THE PATIENT. REPORTEDLY, A SNARE WAS USED TO REMOVE THE SEGMENT, HOWEVER IT WAS UNSUCCESSFUL. AFTER FOUR HOURS, THE DETACHED SEGMENT WAS CUT DOWN AND REMOVED FROM THE PATIENT. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Injury

  MAUDE report 8971108 ↗
• MalfunctionApr 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL U4200220RX PTA BALLOON DILATATION CATHETER EXPERIENCED A DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS MALE AND WEIGHED 180 POUNDS AND WAS 78 YEARS OF AGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519706 ↗
• InjuryApr 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY, THE PTA BALLOON ALLEGEDLY DETACHED AT THE PROXIMAL END AFTER MULTIPLE INFLATION/DEFLATION'S. UPON DETACHMENT THE BALLOON SEGMENT BECAME LODGED AGAINST THE VESSEL WALL OF THE ABDOMINAL AORTA. MULTIPLE ATTEMPTS TO REMOVE THE BALLOON SEGMENT INCLUDING THE USE OF A SNARE WERE UNSUCCESSFUL. THE HEALTH CARE PROVIDER DECIDED TO OPEN THE PATIENTS FEMORAL ARTERY AND SUCCESSFULLY RETRIEVED THE BALLOON SEGMENT. THE VESSEL WAS REPORTED TO BE PATENT WITH GOOD BLOOD FLOW AT THE CONCLUSION OF THE ANGIOPLASTY PROCEDURE. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE.

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

  MAUDE report 7422141 ↗