TRUE DILATATION 0184511Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741097430), received between Feb 27, 2017 and Oct 18, 2024 — classified as 12 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO VALVULOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER PACKAGING WAS DAMAGED BY WATER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478707 ↗
• MalfunctionMar 2, 2023Inflation Problem; Air/Gas in Device; Inflation Problem; Air/Gas in Device

  IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD INFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16468103 ↗
• MalfunctionJan 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO A VALVULOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD LEAK. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092730 ↗
• MalfunctionJul 11, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A VALVULOPLASTY PROCEDURE, THE LABEL WAS ALLEGEDLY STICK WITH THE OUTER BOX. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14975181 ↗
• MalfunctionJul 11, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A VALVULOPLASTY PROCEDURE, THE LABEL WAS ALLEGEDLY STICK WITH THE OUTER BOX. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14975129 ↗
• MalfunctionJun 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRIOR TO A VALVULOPLASTY PROCEDURE THROUGH RIGHT FEMORAL ARTERY, THE BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14612236 ↗
• MalfunctionJan 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION FOR THE VALVULOPLASTY PROCEDURE, FLUID WAS ALLEGEDLY LEAKING AT THE DISTAL END OF THE BALLOON UPON INFLATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176289 ↗
• MalfunctionJul 19, 2019Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 184511 VALVULOPLASTY BALLOON ALLEGEDLY EXPERIENCED A MATERIAL SPLIT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THERE WAS NO REPORTED PATIENT INVOLVEMENT FOR THE MALFUNCTION. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8809534 ↗
• MalfunctionSep 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A TRANSFEMORAL AORTIC VALVE REPLACEMENT, THE PTV BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898685 ↗
• MalfunctionAug 21, 2018Material Rupture

  DURING POST DILATATION, THE TRUE BALLOON RUPTURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7800519 ↗
• MalfunctionMay 30, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE THE BALLOON ALLEGEDLY COULD NOT BE DEFLATED. REPORTEDLY, DURING DEFLATION AN AIR BUBBLE WAS OBSERVED IN THE BALLOON RENDERING THE BALLOON UNUSABLE. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6599744 ↗
• MalfunctionFeb 27, 2017Hole In Material; Hole In Material

  IT WAS REPORTED THAT UPON REMOVING THE DEVICE FROM THE PROTECTIVE SHEATH AN ALLEGED HOLE WAS OBSERVED NEAR MID-SHAFT OF THE BALLOON CATHETER. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6362730 ↗