TRUE DILATATION 0254513Recalls & reported problems
Bard Peripheral Vascular, Inc. · TRUE™ DILATATION Balloon Valvuloplasty Catheter, 25 mm x 4.5 cm,110 cm catheter · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741097461), received between Feb 16, 2018 and May 23, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture4
- Leak/Splash3
- Packaging Problem2
- Device Contamination with Chemical or Other Material1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Material Deformation1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2026Difficult to Remove; Improper or Incorrect Procedure or Method
A PATIENT UNDERWENT VALVULOPLASTY PROCEDURE USING THE TRUE PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS ALLEGEDLY DIFFICULT TO REMOVE THE BALLOON FROM THE INTRODUCER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264747 ↗MalfunctionApr 29, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE BY USING THE TRUE PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SHOULDER OF THE BALLOON ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25025877 ↗MalfunctionFeb 11, 2026Leak/Splash; Peeled/Delaminated; Material Rupture; Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT VALVULOPLASTY PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE BALLOON WAS INSIDE THE PATIENT, THE PHYSICIAN OBSERVED A SMALL LEAK NEAR THE SHOULDER OF THE BALLOON. THE DEVICE WAS IMMEDIATELY REMOVED, INSPECTED, AND SUBSEQUENTLY BAGGED FOR RETURN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312561 ↗MalfunctionJan 23, 2026Leak/Splash
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE PTA TRUE DILATION BALLOON VALVULOPLASTY CATHETER. DURING THE PROCEDURE, THE SALINE/CONTRAST COMING FROM JUST PROXIMAL TO BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24158765 ↗MalfunctionOct 17, 2024Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED THAT PRIOR TO VALVULOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD WATER DAMAGE. ADDITIONAL FOLLOW-UP WITH THE FACILITY FOUND THAT THE SECONDARY PACKAGING (DEVICE CARTON) WAS UNOPENED, AND THERE WERE NO VISIBLE TEARS, RIPS, OR HOLES ON THE DEVICES. THE COMPLAINANT INDICATED THAT THE DAMAGE APPEARED TO BE RELATED TO SHIPPING, AS BOTH THE OUTER SHIPPING CARTON AND SECONDARY PACKAGING SHOWED SIGNS OF WATER DAMAGE. THE DEVICES WERE NOT USED ON ANY PATIENTS SINCE THE DAMAGE WAS IDENTIFIED DURING INSPECTION AT THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20472620 ↗MalfunctionFeb 20, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT PRIOR TO A VALVULOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY LEAKED. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738814 ↗MalfunctionAug 26, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT PRIOR TO A VALVULOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15299962 ↗MalfunctionOct 26, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0254513 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10736516 ↗MalfunctionFeb 16, 2018Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE INNER PACKAGING OF THE VALVULOPLASTY BALLOON WAS ALLEGEDLY NOT SEALED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7277564 ↗
Other Balloon aortic valvuloplasty devices
- TRUE DILATATION 0224512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty23 reports
- TRUE DILATATION 0204511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty21 reports
- TRUE DILATATION 0244512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty2 deaths19 reports
- TRUE DILATATION 0184511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty12 reports
- TRUE DILATATION 0264513Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty11 reports
- TRUE DILATATION 0234512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty1 death10 reports
- TRUE DILATATION 0214512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty10 reports
- TRUE FLOW TF0203511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.