Rival® RV135415Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741063435), received between Oct 2, 2018 and Jul 20, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (2 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.

• MalfunctionJul 20, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM AND THE CONTRAST AGENT LEAKED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194467 ↗
• InjuryJul 13, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON TIP ALLEGEDLY RUPTURED AND DETACHED. IT WAS FURTHER REPORTED THAT A CUT DOWN PROCEDURE WAS REQUIRED TO REMOVE THE DETACHED MATERIAL. THERE WERE NO FURTHER REPORTED COMPLICATIONS TO THE PATIENT.

  Patient problems: Injury

  MAUDE report 10262648 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT THE SUPERFICIAL FEMORAL ARTERY WAS OBSERVED TO HAVE A GRADE B NON-FLOW LIMITING DISSECTION AFTER PRE-DILATION WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER. IT WAS FURTHER REPORTED THAT THE DISEASED VESSEL WAS TREATED WITH TWO DRUG COATED PTA BALLOONS AND A GRADE C FLOW-LIMITING, DISSECTION WAS OBSERVED AFTER TREATMENT. REPORTEDLY, THE PRE-DILATION DEVICE WAS USED FOR POST-DILATION TO RESOLVE THE DISSECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Vascular Dissection

  MAUDE report 7928594 ↗