TRUE DILATATION 0244512Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741091018), received between Dec 20, 2016 and Jul 30, 2026 — classified as 2 deaths, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Deflation Problem; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50081958 ↗
• MalfunctionMay 20, 2026Deflation Problem; Difficult to Remove; Device-Device Incompatibility

  A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE USING THE TRUE BALLOON. DURING THE PROCEDURE, THE BALLOON INFLATED BUT COULD NOT GET IT COME DOWN. IT WAS FURTHER REPORTED THAT THE BALLOON GOT STUCK ON THE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226392 ↗
• MalfunctionNov 20, 2025Inflation Problem; Inflation Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN VALVULOPLASTY PROCEDURE USING TRUE BALLOON. PRIOR TO THE PROCEDURE, AIR WAS DRAWING BACK DURING ASPIRATION. THE PHYSICIAN ATTEMPTED TO EXCHANGE THE 60ML SYRINGE AND THE HIGH-PRESSURE STOP COCK IN CASE EITHER OF THOSE PIECES WERE FAULTY. THE BALLOON WAS SWAPPED FOR A NEW ONE WHICH WORKED PERFECTLY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601890 ↗
• MalfunctionOct 30, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT A TRANS-AORTIC TAVR PROCEDURE VIA RIGHT ANTERIOR MINI THORACOTOMY USING THE TRUE DILATATION CATHETER. A BOSTON SCIENTIFIC SAFARI2 EXTRA SMALL 275CM BALLOON CATHETER WAS USED TO FRACTURE AN OLD BIOPROSTHETIC AORTIC VALVE IMPLANTED APPROXIMATELY 8 YEARS PRIOR. DURING INFLATION OF THE BALLOON WITHIN THE AORTIC VALVE, IT APPEARED TO NOT INFLATE FULLY. UPON DEFLATION AND REMOVAL, IT WAS NOTED THAT APPROXIMATELY 20¿30ML OF CONTRAST WAS UNACCOUNTED. UPON EXTERNAL INSPECTION OF THE BALLOON, A HOLE WAS OBSERVED, AND CONTRAST WAS SEEN SQUIRTING OUT WHEN INFLATED OUTSIDE THE BODY, CONFIRMING A DEVICE LEAK. THE GRADIENT ACROSS THE VALVE WAS LOW, AND NO FURTHER INTERVENTION WAS DEEMED NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23422588 ↗
• MalfunctionJul 14, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025 A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE USING THE TRUE DILATATION CATHETER. DURING PROCEDURE, IT WAS REPORTED THAT WHEN THE PHYSICIAN RETRACTED THE BALLOON OVER THE WIRE, WHILE PULLING THE BALLOON THROUGH THE SHEATH, A LOT OF RESISTANCE WAS FELT. REPORTEDLY, THE PHYSICIAN HAD TO PULL REALLY HARD, WHEN THE BALLOON FINALLY CAME LOOSE AND VISUALLY, THE BALLOON ALSO SEEMED TO BE REWRAPPED WELL. THERE WAS NO REPORT PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491442 ↗
• MalfunctionOct 17, 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 20472618 ↗
• MalfunctionMay 18, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING PREPARATION OF A VALVULOPLASTY PROCEDURE, THERE WAS ALLEGEDLY A TWENTY-TWO MILLIMETER BALLOON CATHETER IN THE CARTON INSTEAD OF TWENTY-FOUR MILLIMETER BALLOON CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16951749 ↗
• MalfunctionNov 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT POST TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE , THE PTV BALLOON ALLEGEDLY HAD HOLES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851426 ↗
• DeathSep 9, 2021Difficult to Remove; Material Rupture; Material Deformation; Difficult to Remove; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED CAUSING TRAUMA TO THE ILIAC ARTERY AND SUBSEQUENT HEMORRHAGE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DIFFICULT TO BE RETRACTED. THE PATIENT REPORTEDLY EXPIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 12446061 ↗
• DeathAug 10, 2021Retraction Problem; Material Rupture; Material Split, Cut or Torn

  BALLOON DEPLOYED AND RUPTURED. WHEN BALLOON WAS RETRACTED INTO SHEATH, SHEATH WAS TORN. BALLOON AND SHEATH PULLED OUT IN TANDEM CASING TRAUMA TO ILIAC ARTERY AND SUBSEQUENT HEMORRHAGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 12300471 ↗
• MalfunctionNov 6, 2020Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10799070 ↗
• MalfunctionOct 26, 2020Break; Deflation Problem; Inflation Problem; Break; Deflation Problem; Inflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0244512 VALVULOPLASTY BALLOON CATHETER ALLEGEDLY BREAK, LEAK, DEFLATION PROBLEM, RETRACTION PROBLEM, INFLATION PROBLEM, AND MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6)YEARS OLD MALE PATIENT WEIGHS(B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10735961 ↗
• MalfunctionJul 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0244512 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10276601 ↗
• MalfunctionJan 9, 2020Failure to Fold; Retraction Problem; Failure to Fold; Retraction Problem

  THIS REPORT SUMMARIZES 2 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 244512 TRUE BALLOON VALVULOPLASTY CATHETER ALLEGEDLY EXPERIENCED FAILURE TO FOLD AND A RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE TWO MALFUNCTIONS INVOLVED TWO PATIENTS WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT, AND GENDERS OF THE TWO PATIENTS WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9572523 ↗
• MalfunctionSep 27, 2017Deflation Problem; Aspiration Issue; Deflation Problem; Aspiration Issue

  IT WAS REPORTED THAT DURING PREPARATION, THE BALLOON ALLEGEDLY WAS DIFFICULT TO DEFLATE, RENDERING THE DEVICE UNUSABLE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY ASPIRATED AIR DURING DEFLATION. REPORTEDLY, ANOTHER VALVULOPLASTY BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6898272 ↗
• MalfunctionAug 10, 2017Aspiration Issue; Aspiration Issue

  IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE THE BALLOON CATHETER ALLEGEDLY ASPIRATED WHILE PULLING NEGATIVE PRESSURE. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6786862 ↗
• MalfunctionMar 29, 2017Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE, AN ALLEGED CRACK WAS OBSERVED ON THE INFLATION HUB OF THE BALLOON AND THEN LEAKED WHEN ATTEMPTED TO FLUSH. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6445050 ↗
• MalfunctionFeb 16, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN AORTIC VALVULOPLASTY PROCEDURE, AN ALLEGED LEAK WAS IDENTIFIED ON THE BALLOON. THE BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6337637 ↗
• MalfunctionDec 20, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE, AN ALLEGED BALLOON LEAK WAS OBSERVED ON THE BALLOON. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6191261 ↗