TRUE DILATATION T264513Recalls & reported problems
Bard Peripheral Vascular, Inc. · TRUE™ DILATATION Balloon Valvuloplasty Catheter, 26 mm x 4.5 cm, 55 cm catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741097553), received between Jul 14, 2026 and Aug 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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
- Difficult to Remove1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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