TRUE FLOW TF0203511Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741097652), received between Aug 21, 2018 and Jul 8, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Difficult to Remove; Improper or Incorrect Procedure or Method; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE USING THE TRUE FLOW BALLOON. DURING BALLOON REMOVAL, RESISTANCE WAS ENCOUNTERED, AND THE BALLOON WAS NOTED TO BE SLIGHTLY DEFORMED. THE PROCEDURE WAS COMPLETED WITHOUT REMOVAL OF THE KEVLAR PROTECTIVE LAYER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25751326 ↗
• MalfunctionMar 13, 2026Failure to Advance; Device-Device Incompatibility; Material Deformation

  ON (B)(6) 2026 A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE USING THE TRUEFLOW BALLOON. DURING THE PROCEDURE THE BALLOON CATHETER LUMEN WAS ALLEGEDLY COLLAPSED AND GUIDEWIRE UNABLE TO PASS THROUGH 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 24588071 ↗
• MalfunctionOct 30, 2024Inflation Problem; Failure to Advance; Inflation Problem; Failure to Advance

  IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE PTV BALLOON ALLEGEDLY DID NOT EXPAND DURING INSUFFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565129 ↗
• MalfunctionFeb 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY HAD A INFLATION PROBLEM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13616272 ↗
• MalfunctionOct 11, 2021Difficult to Insert; Device-Device Incompatibility; Difficult to Advance; Difficult to Insert; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT PRIOR TO A VALVULOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY IN ADVANCING INTO THE SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606176 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT ON THE SAME DAY OF THE PROCEDURE, COMPLETE HEART BLOCK OCCURRED. THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Heart Block

  MAUDE report 11918542 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT ON THE SAME DAY OF THE PROCEDURE, COMPLETE HEART BLOCK OCCURRED. THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Heart Block

  MAUDE report 11918519 ↗
• MalfunctionJul 22, 2019Failure to Fold; Difficult to Insert; Suction Problem; Failure to Fold; Difficult to Insert; Suction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL TF0203511. BALLOON VALVULOPLASTY CATHETER ALLEGEDLY EXPERIENCED FAILURE TO FOLD, DIFFICULT TO INSERT AND ASPIRATION ISSUE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID NOT INVOLVE PATIENT WITH NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8814308 ↗
• MalfunctionNov 29, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PREPARATION FOR A VALVULOPLASTY PROCEDURE, THE BALLOON VALVULOPLASTY CATHETER ALLEGEDLY WOULD NOT THREAD ONTO THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE BALLOON VALVULOPLASTY CATHETER WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY PERFORMED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8118554 ↗
• MalfunctionAug 21, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN AORTIC VALVULOPLASTY, THE PTV BALLOON ALLEGEDLY HAD INFLATION ISSUES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7803609 ↗