Rival® RV135610Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741063732), received between Mar 7, 2018 and Apr 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL RV135610 PTA DILATATION CATHETER ALLEGEDLY RUPTURED. THIS REPORT WAS RECEIVED FROM ONE SOURCES. THE DEVICE WAS USED INSIDE THE PATIENT, WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS A SIXTY-SIX YEAR-OLD MALE, OF SIXTY-NINE KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519480 ↗
• MalfunctionMar 7, 2018Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT PRIOR TO THE FIRST INFLATION OF A PTA BALLOON DILATATION CATHETER, THE CATHETER ALLEGEDLY BECAME LODGED WITHIN THE SHEATH; THEREFORE, THE CATHETER AND THE SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT WITHOUT INCIDENT. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7322447 ↗