TRUE DILATATION 0204511Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741090998), received between Feb 16, 2017 and Sep 2, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 30, 2026Difficult to Remove; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50080488 ↗
• MalfunctionMay 24, 2026Difficult to Remove; Improper or Incorrect Procedure or Method

  A PATIENT UNDERWENT VALVULOPLASTY PROCEDURE USING THE TRUE PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS DIFFICULT TO REMOVE THE BALLOON FROM THE INTRODUCER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267283 ↗
• MalfunctionApr 2, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A VALVULOPLASTY PROCEDURE USING THE TRUE CATHETER BALLOON. PRIOR TO THE PROCEDURE, THE BALLOON ALLEGEDLY PERFORATED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763952 ↗
• MalfunctionMar 30, 2026Deflation Problem; Air/Gas in Device

  ON (B)(6) 2026, PRIOR TO A VALVULOPLASTY PROCEDURE USING THE TRUEFLOW BALLOON. PRIOR TO THE PROCEDURE DEVICE ALLEGEDLY FAILED TO DEFLATE PROPERLY, AND AIR WAS OBSERVED BEING WITHDRAWN DURING THE DEFLATION PROCESS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725115 ↗
• MalfunctionMar 2, 2026Leak/Splash; Unraveled Material

  ON (B)(6) 2026, A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE BY USING THE TRUE BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEAK IS ALLEGEDLY OBSERVED AT THE CONNECTION WHERE THE BALLOON IS ATTACHED TO THE TUBING. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480719 ↗
• MalfunctionDec 2, 2025Break; Material Rupture; Break; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE USING TRUE DILATION BALLOON VIA THE ACCESS SITE OF RIGHT GROIN TO TREAT THE TRANSCATHETER AORTIC VALVE REPLACEMENT. DURING THE PROCEDURE, THE BALLOON HAD A PINHOLE RUPTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693799 ↗
• InjuryNov 30, 2021Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE IN AORTIC VALVE VIA LARGE BORE ACCESS THROUGH RIGHT FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT THIRD INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT DETACHED AND THE FRAGMENTS WERE LEFT IN THE JUXTA RENAL AORTIC POSITION. REPORTEDLY, THE BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE. THE PATIENT CURRENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12889096 ↗
• MalfunctionDec 19, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION FOR A VALVULOPLASTY PROCEDURE, THE PTV BALLOON ALLEGEDLY HAD A LEAK AT THE INFLATION HUB. ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8182338 ↗
• InjuryApr 11, 2018Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TAVR PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED DURING AN INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE 14FR SHEATH. UPON REMOVING THE BALLOON AND SHEATH TOGETHER AS ONE UNIT, A SEGMENT OF THE BALLOON MATERIAL ALLEGEDLY DETACHED AND BECAME LODGED IN THE EXTERNAL ILIAC ARTERY. MULTIPLE ATTEMPTS TO REMOVE THE BALLOON SEGMENT INCLUDING UPSIZING TO A 16FR SHEATH AND THE USE OF A SNARE WERE UNSUCCESSFUL. THE HEALTH CARE PROVIDER DECIDED TO SEND THE PATIENT TO SURGERY FOR REMOVAL OF THE BALLOON SEGMENT. THERE WAS NO REPORTED PATIENT INJURY POST SURGICAL EXTRACTION OF THE BALLOON SEGMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7421972 ↗
• MalfunctionFeb 15, 2018Aspiration Issue; Aspiration Issue

  IT WAS REPORTED THAT DURING AN AORTIC VALVULOPLASTY PROCEDURE, THE BALLOON CATHETER ALLEGEDLY ASPIRATED AIR AT THE PLASTIC BIFURCATION. 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 7274020 ↗
• InjuryJan 24, 2018Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT DURING A PROCEDURE TO RELEASE A BUILDUP OF FLUID PRESSURE IN THE PERICARDIUM, THE VALVULOPLASTY BALLOON BEGAN TO WATERMELON SEED INTO THE PERICARDIUM UPON INFLATION. IT WAS FURTHER REPORTED THAT WHEN THE HEALTH CARE PROVIDER (HCP) DEFLATED AND PULLED THE BALLOON FOR REPOSITIONING, BALLOON FIBER MATERIAL DETACHED FROM THE CATHETER AND REMAINED IN THE PERICARDIAL SAC. THE HCP PROCEEDED TO OPEN THE PATIENT¿S CHEST SURGICALLY TO RETRIEVE THE BALLOON FIBER SUCCESSFULLY. THE PATIENT WAS REPORTED AS ASYMPTOMATIC POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7217468 ↗
• MalfunctionDec 8, 2017Deflation Problem; Aspiration Issue; Deflation Problem; Aspiration Issue

  IT WAS REPORTED THAT DURING PREPARATION FOR A TAVI PROCEDURE, THE VALVULOPLASTY BALLOON ALLEGEDLY COULD NOT BE ASPIRATED WITH A SYRINGE. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7102433 ↗
• MalfunctionOct 18, 2017Inflation Problem; Aspiration Issue; Inflation Problem; Aspiration Issue

  IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE THERE WAS AN ALLEGED INFLATION ISSUE WITH THE BALLOON. THERE WAS NO REPORTED RETRACTION ISSUE THROUGH THE SHEATH. THE BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6960026 ↗
• MalfunctionAug 7, 2017Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ALLEGED DEVICE MALFUNCTION OCCURRED WITH THE PTA BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6772561 ↗
• MalfunctionJun 26, 2017Aspiration Issue; Aspiration Issue

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

  Patient problems: No Patient Involvement

  MAUDE report 6667635 ↗
• MalfunctionApr 26, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE, AN ALLEGED LEAK WAS FOUND ON THE BALLOON CATHETER SHAFT. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6523538 ↗
• MalfunctionApr 26, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE, AN ALLEGED LEAK WAS FOUND ON THE BALLOON CATHETER SHAFT. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6522765 ↗
• MalfunctionFeb 16, 2017Break; Hole In Material; Break; 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 PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6337638 ↗
• MalfunctionFeb 16, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN AORTIC VALVULOPLASTY PROCEDURE, A LEAK WAS IDENTIFIED ON THE BALLOON. THE BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6335420 ↗