Rival® RV135410Recalls & reported problems
Bard Peripheral Vascular, Inc. · Rival® PTA Balloon Dilatation Catheter 4 mm x 10 cm, 135 cm catheter · Class 2
All models of Rival (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741063404), received between Jan 16, 2020 and Sep 20, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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
Device problems
- Material Rupture3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12496015 ↗MalfunctionApr 15, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RV135410 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS REPORTEDLY A (B)(6) YEAR OLD MALE WEIGHING (B)(6) KGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9965264 ↗MalfunctionJan 16, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RV135410 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE BALLOON MATERIAL RUPTURE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. PATIENT'S AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9598155 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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