TRUE DILATATIONRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 124
- Deaths reported
- 3
- Injuries reported
- 10
- Recalls
- 0
We found 10 models of TRUE DILATATION by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 124 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2016 and Sep 15, 2026 — classified as 3 deaths, 10 injuries, 111 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (39 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
Reports received per month, all models
Most reported TRUE DILATATION problems
Device problems
- Material Rupture39
- Leak/Splash26
- Difficult to Remove18
- Aspiration Issue16
- Deflation Problem16
- Break10
- Retraction Problem10
- Inflation Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- No Patient Involvement28
- No Consequences Or Impact To Patient25
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Known Impact Or Consequence To Patient4
- Hemorrhage/Blood Loss/Bleeding2
- Perforation2
- Blood Loss1
TRUE DILATATION models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRUE DILATATION 0224512Balloon aortic valvuloplasty23 reports
- TRUE DILATATION 0204511Balloon aortic valvuloplasty21 reports
- TRUE DILATATION 0244512Balloon aortic valvuloplasty2 deaths19 reports
- TRUE DILATATION 0184511Balloon aortic valvuloplasty12 reports
- TRUE DILATATION 0264513Balloon aortic valvuloplasty11 reports
- TRUE DILATATION 0214512Balloon aortic valvuloplasty10 reports
- TRUE DILATATION 0234512Balloon aortic valvuloplasty1 death10 reports
- TRUE DILATATION 0254513Balloon aortic valvuloplasty9 reports
- TRUE DILATATION 0284514Balloon aortic valvuloplasty7 reports
- TRUE DILATATION T264513Balloon aortic valvuloplasty2 reports
Recent TRUE DILATATION adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 2, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565710 ↗MalfunctionSep 2, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50561896 ↗MalfunctionAug 26, 2026Difficult to Remove; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50446324 ↗MalfunctionAug 6, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50156373 ↗MalfunctionAug 5, 2026Difficult to Remove; Material Rupture
It was reported that the patient underwent a valvuloplasty procedure using the True balloon. During balloon removal, resistance was encountered, and the balloon was noted to be ruptured. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140900 ↗MalfunctionAug 5, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137947 ↗MalfunctionAug 4, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50126718 ↗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 30, 2026Deflation Problem; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081958 ↗MalfunctionJul 30, 2026Difficult to Remove; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50080488 ↗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 ↗MalfunctionJul 15, 2026
TWO DEVICES: 1. DURING A TAVR [TRANSCATHETER AORTIC VALVE REPLACEMENT] VALVE PROCEDURE, A BARD TRUE DILATION BALLOON (26MM) BURST DURING NORMAL USE. THE MANUFACTURER WAS NOTIFIED BY THE CATH LAB PERSONNEL¿NO HARM TO THE PATIENT. 2. THE SURGEON INFLATED THE TRUE DILATION BALLOON, AND IT RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25826152 ↗MalfunctionJul 14, 2026
USING MICROPUNCTURE TECHNIQUE AND ULTRASOUND GUIDANCE THE RIGHT COMMON FEMORAL VEIN WAS ACCESSED, AND 2 PERCLOSES WERE PLACED IN A PRECLOSE FASHION. ULTRASOUND-GUIDED LEFT FEMORAL A-LINE [ARTERIAL LINE] WAS THEN PLACED WITH MICROPUNCTURE TECHNIQUE AND PLACING A 4 FRENCH A-LINE FOR MONITORING PURPOSES. AN 8 FRENCH SHEATH WAS THEN PLACED, AND A J-TIPPED GUIDEWIRE AND PIGTAIL CATHETER WERE THEN USED TO CROSS THE STENOTIC TRICUSPID VALVE. HEPARIN WAS ADMINISTERED ACHIEVING ACT [ACTIVATED CLOTTING TIME] GREATER THAN 250. THE J-WIRE WAS THEN EXCHANGED FOR A SAFARI WIRE WITH AN EXTRA SMALL CURVE. THE 14 FRENCH EDWARDS E SHEATH WAS THEN PLACED, AND THEN THROUGH THE E SHEATH A 26 MM TRUE BALLOON WAS THEN ADVANCED AND CROSSED THE PROSTHETIC TRICUSPID VALVE WITHOUT DIFFICULTY. THEN USING A VALVE FRACTURE TECHNIQUE, A TRICUSPID VALVULOPLASTY WAS PERFORMED WITH THE 26 MM TRUE BALLOON. THE VALVE WAS ABLE TO BE FRACTURED, BUT JUST AFTER FRACTURING, THE TRUE BALLOON RUPTURED. THE BALLOON WAS UNABLE TO BE RETRIEVED THROUGH THE SHEATH. A DECISION WAS MADE TO COMPLETE THE PROCEDURE FROM THE LEFT SIDE AS A CUTDOWN WOULD BE NECESSARY TO RETRIEVE THE TRUE BALLOON. THE PATIENT WAS UPGRADED FROM MAC [MONI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812206 ↗
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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