TRUE DILATATION 0234512Recalls & reported problems
Bard Peripheral Vascular, Inc. · TRUE™ DILATATION Balloon Valvuloplasty Catheter, 23 mm x 4.5 cm,110 cm catheter · Class 2
All models of TRUE DILATATION (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741097454), received between Mar 5, 2020 and Sep 15, 2026 — classified as 1 death, 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove4
- Improper or Incorrect Procedure or Method2
- Leak/Splash2
- Material Rupture2
- Adverse Event Without Identified Device or Use Problem1
- Air/Gas in Device1
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Death1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Difficult to Remove
On (b)(6), 2026, a patient underwent a valvuloplasty procedure using a True Balloon Catheter. During the procedure, the balloon catheter could not be retracted into the sheath as intended, resulting in difficulty removing the sheath. To facilitate device retrieval, the balloon catheter was snared through a secondary sheath via contralateral femoral access and externalized through the left femoral access site. The balloon catheter was subsequently cut, and the remaining catheter shaft was extracted through the RFA sheath. The procedure was completed using another device. The patient's current status is unknown.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50766770 ↗MalfunctionAug 4, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50126718 ↗MalfunctionMay 23, 2026Difficult to Remove; Improper or Incorrect Procedure or Method
A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE USING THE TRUE PTA BALLOON. IT WAS FURTHER DURING THE PROCEDURE, IT WAS DIFFICULT TO REMOVE THE BALLOON FROM THE INTRODUCER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264746 ↗MalfunctionMay 21, 2026Difficult to Remove; Improper or Incorrect Procedure or Method
ON (B)(6) 2026, A PATIENT UNDERWENT VALVULOPLASTY PROCEDURE USING THE TRUE PTA BALLOON. POST PROCEDURE, IT WAS DIFFICULT TO REMOVE THE BALLOON FROM THE INTRODUCER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25239535 ↗MalfunctionDec 26, 2025Deflation Problem; Air/Gas in Device; Deflation Problem; Air/Gas in Device
ON (B)(6) 2025, A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE, IT WAS REPORTED THAT DURING THE PREPARATION OF A TRUE BALLOON, ALLEGEDLY FOUND IT COULD NOT BE DEFLATED. FURTHER, AIR BUBBLES WERE COMING OUT OF THE CATHETER ALL THE TIME. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894831 ↗MalfunctionDec 8, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT PREPPED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE TRUE VALVULOPLASTY BALLOON CATHETER. PRIOR TO THE PROCEDURE, DURING PREPARATION, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741364 ↗MalfunctionAug 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19959148 ↗MalfunctionJun 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD LEAK AT 2 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17236505 ↗MalfunctionFeb 22, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, AIR WAS ALLEGEDLY FLOWING TO THE SYRINGE CONSTANTLY AS A RESULT IT WAS UNABLE TO CHECK THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13577348 ↗DeathMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING VALVULOPLASTY PROCEDURE, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS AND CARDIO-PULMONARY ARREST, WHICH REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). IT WAS FURTHER REPORTED THAT AORTOGRAPHY CONFIRMED SEVERE AORTIC INSUFFICIENCY (AI), HOWEVER, AFTER IMPLANTATION OF BIOLOGIC AORTIC VALVE, VENTRICULAR FIBRILLATION (VF) WAS RESISTANT TO DEFIBRILLATION AND CPR. REPORTEDLY, THE PATIENT EXPIRED. THERE WAS NO DEVICE DEFICIENCY OR MALFUNCTION.
Patient problems: Death
MAUDE report 9794980 ↗
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 FLOW TF0203511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty10 reports
- TRUE DILATATION 0214512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty10 reports
- TRUE DILATATION 0254513Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty9 reports
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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