TRUE DILATATION 0284514Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741097478), received between Jan 10, 2020 and Aug 5, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50137947 ↗
• 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 ↗
• MalfunctionJan 2, 2025Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A BALLOON AORTIC VALVULOPLASTY PROCEDURE IN THE PULMONARY VALVE, THE BALLOON ALLEGEDLY FAILED TO PASS THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON MIGRATED TOWARDS THE DISTAL END OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21052635 ↗
• MalfunctionMay 16, 2024Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  T WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A LEAK ON THE SHAFT. IT WAS FURTHER REPORTED THAT THE AIR ALLEGEDLY KEPT COMING IN WHEN TRYING TO DEFLATE THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19328691 ↗
• MalfunctionApr 17, 2024Break; Deflation Problem; Difficult to Remove; Break; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE PTV BALLOON ALLEGEDLY PARTIALLY SEPARATED AT THE SHAFT AND THE BALLOON ALLEGEDLY WASN'T COMPLETELY DEFLATED. IT WAS FURTHER REPORTED THAT THE ACTUAL BALLOON WAS STILL CONNECTED VIA THE LUMEN TO FILL THE BALLOON. FURTHERMORE, IT WAS ALLEGEDLY HARD TO REMOVE THROUGH THE SHEATH. REPORTEDLY, IT WAS REMOVED ALL TOGETHER AND THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19123674 ↗
• InjuryJan 23, 2024Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE PTV BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY DETACHED FROM THE CATHETER SHAFT BUT STAYED ATTACHED AT THE TIP WHICH CAUSED IT TO FOLD OVER ITSELF AND PREVENTED REMOVAL FROM THE VEIN. FURTHERMORE, THE PHYSICIAN WAS ALLEGEDLY UNABLE TO PULL THE BALLOON OUT OF THE SHEATH. REPORTEDLY, A RIGHT COMMON FEMORAL ARTERY EXPLORATION WAS MADE FOR FOREIGN BODY REMOVAL THROUGH THE COMMON FEMORAL VEIN LONGITUDINAL VENOTOMY, AND PRIMARY REPAIR OF RIGHT COMMON FEMORAL VEIN VENOTOMY WAS PERFORMED TO REMOVE THE DEVICE AND REPAIR VASCULATURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18564074 ↗
• MalfunctionJan 10, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0284514 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE 2 MATERIAL RUPTURES, 2 INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THERE WAS NO PROVIDED PATIENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9576566 ↗