RivalRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 15 models of Rival by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2016 and Apr 19, 2022 — classified as 3 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Rival problems
Device problems
- Material Rupture15
- Detachment of Device or Device Component5
- Retraction Problem3
- Leak/Splash2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Deflation Problem1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient9
- Blood Loss1
- Injury1
- No Patient Involvement1
- Vascular Dissection1
Rival models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Rival® RV135410CATHETER, PERCUTANEOUS3 reports
- Rival® RV135415Catheter, angioplasty, peripheral, transluminal3 reports
- Rival® RV8054Catheter, angioplasty, peripheral, transluminal2 reports
- Rival® RV13556CATHETER, PERCUTANEOUS2 reports
- Rival® RV135610CATHETER, PERCUTANEOUS2 reports
- Rival® RV8044CATHETER, PERCUTANEOUS1 report
- Rival® RV13544CATHETER, PERCUTANEOUS1 report
- Rival® RV8056CATHETER, PERCUTANEOUS1 report
- Rival® RV8064Catheter, angioplasty, peripheral, transluminal1 report
- Rival® RV13564Catheter, angioplasty, peripheral, transluminal1 report
- Rival® RV8074Catheter, angioplasty, peripheral, transluminal1 report
- Rival® RV8084Catheter, angioplasty, peripheral, transluminal1 report
- Rival® RV13586Catheter, angioplasty, peripheral, transluminal1 report
- Rival® RV135515CATHETER, PERCUTANEOUS1 report
- Rival® RV135615Catheter, angioplasty, peripheral, transluminal1 report
Recent Rival adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE IN THE LOWER EXTREMITIES, THE BALLOON SHAFT ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14139783 ↗MalfunctionMar 21, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13839795 ↗MalfunctionNov 25, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN LEFT ANTERIOR ARM, THE PTA BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12876527 ↗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 ↗MalfunctionJul 29, 2021Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD AN INFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12243855 ↗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 ↗MalfunctionApr 1, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CHRONIC TOTAL OCCLUSION IN SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11600677 ↗MalfunctionApr 1, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY, THE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11600676 ↗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 ↗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 ↗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 ↗InjuryOct 22, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR ARTERIAL THROMBOSIS IN THE LEFT A/V FOREARM FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED EXCESSIVE BLOOD LOSS. PATIENT STATUS IS UNKNOWN.
Patient problems: Blood Loss
MAUDE report 9221895 ↗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 ↗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 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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