TRUE FLOW TF0243514Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741097676), received between Dec 20, 2016 and Jul 6, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON RECEIVING THE VALVULOPLASTY BALLOON, THE NEW LABEL WITH A NEW EXPIRATION DATE WAS PLACED OVER AN OLD LABEL WITH AN EXPIRATION DATE OF OVER A YEAR. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7668019 ↗
• MalfunctionMar 22, 2018Peeled/Delaminated; Retraction Problem; Detachment of Device or Device Component; Peeled/Delaminated; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN AORTIC VALVULOPLASTY PROCEDURE THE BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE THROUGH THE 14FR SHEATH. REPORTEDLY, THE BALLOON WAS ABLE TO BE REMOVED FROM THE SHEATH AFTER MULTIPLE ATTEMPTS. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7364379 ↗
• MalfunctionSep 7, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT POST TAVR PROCEDURE, THERE WAS AN AORTIC INSUFFICIENCY (AI) REQUIRING POST DILATATION WITH A VALVULOPLASTY BALLOON WHICH ALLEGEDLY RUPTURED AT 12 ATM. THE BALLOON WAS REMOVED AND THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON FOR A SUCCESSFUL POST TAVR BAV. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6850541 ↗
• MalfunctionJul 24, 2017Loss of or Failure to Bond; Device Operates Differently Than Expected; Loss of or Failure to Bond; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ONE OF THE EIGHT BALLOONS ALLEGEDLY BECAME UNBOUND. IT WAS FURTHER REPORTED THAT THE MALFUNCTION MAY HAVE OCCURRED EITHER DURING THE PROCEDURE OR AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6736184 ↗
• MalfunctionDec 20, 2016Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE AN ALLEGED DEFLATION ISSUE OCCURRED. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6191482 ↗