Rival® RV13556Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741063527), received between Oct 16, 2019 and Dec 4, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionDec 4, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE ANGIOPLASTY PROCEDURE, THE PACKAGE OF THE DEVICE ALLEGEDLY OPENED WITH A SPLIT. IT WAS FURTHER REPORTED THAT THE STERILE PART WAS EXPOSED EXTERNALLY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10948505 ↗
• MalfunctionOct 16, 2019Detachment 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 RV13556 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THERE WAS NO PATIENT CONTACT. THE PATIENT IS A (B)(6) YEAR OLD MALE WHO'S WEIGHT IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 9198952 ↗