TRUE DILATATION 0214512Recalls & reported problems
Bard Peripheral Vascular, Inc. · TRUE™ DILATATION Balloon Valvuloplasty Catheter, 21 mm x 4.5 cm, 110 cm catheter · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741097447), received between Feb 15, 2018 and Sep 2, 2026 — classified as 1 injury, 9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture3
- Aspiration Issue2
- Inflation Problem2
- Deflation Problem1
- Device Damaged Prior to Use1
- Material Deformation1
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- Blood Loss1
- Vascular Dissection1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565710 ↗MalfunctionJul 30, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081961 ↗MalfunctionJul 30, 2026Inflation Problem; Material Rupture
On (b)(6) 2026, a patient underwent a valvuloplasty procedure using a True balloon catheter. Prior to use, during device preparation and balloon inflation, it was observed that only approximately 20 cc of contrast medium could be injected despite the balloon having a specified inflation volume of 25 cc. Further inspection reportedly revealed a balloon rupture. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081959 ↗MalfunctionJul 27, 2026Inflation Problem
On (b)(6) 2026, a patient underwent a valvuloplasty procedure using a True PTA balloon. During balloon inflation, only approximately 20 cc of contrast medium could be injected, although the specified balloon volume was 25 cc, a clear inflation problem was detected. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50021275 ↗MalfunctionDec 28, 2021Deflation Problem; Deflation Problem
IT WAS REPORTED THAT PRIOR TO A VALVULOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD DEFLATION ISSUE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13092377 ↗MalfunctionOct 15, 2019Device Damaged Prior to Use; Device Damaged Prior to Use
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 214512 BALLOON VALVULOPLASTY CATHETER ALLEGEDLY EXPERIENCED DAMAGED DEVICE PRIOR TO USE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THERE WAS NO REPORTED PATIENT CONTACT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 9194957 ↗MalfunctionDec 6, 2018Suction Problem; Suction Problem
IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE THE BALLOON CATHETER ALLEGEDLY WAS ASPIRATING AIR. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8138343 ↗InjuryMay 31, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING A TAVR PROCEDURE, THE VALVULOPLASTY BALLOON ALLEGEDLY RUPTURED AND BECAME LODGED IN THE VESSEL. SURGICAL RETRIEVAL OF THE BALLOON WAS REQUIRED AND A VESSEL DISSECTION REPAIR OF THE LEFT COMMON ILIAC AND ABDOMINAL AORTIC ARTERY. THERE WAS NO REPORTED PATIENT INJURY POST SURGICAL EXTRACTION.
Patient problems: Blood Loss; Vascular Dissection
MAUDE report 7559034 ↗MalfunctionFeb 15, 2018Aspiration Issue; Aspiration Issue
IT WAS REPORTED THAT THE VALVULOPLASTY BALLOON ALLEGEDLY HAD AN AIR BUBBLE IN THE SYRINGE. IT IS UNKNOWN IF THE DEVICE WAS USED ON A PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274022 ↗MalfunctionFeb 15, 2018Aspiration Issue; Aspiration Issue
IT WAS REPORTED THAT THE VALVULOPLASTY BALLOON ALLEGEDLY HAD AN AIR BUBBLE IN THE SYRINGE. IT IS UNKNOWN IF THE DEVICE WAS USED ON A PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7273772 ↗
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 FLOW TF0203511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty10 reports
- TRUE DILATATION 0254513Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.