TRUE DILATATION 0264513Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741096631), received between Mar 27, 2017 and Aug 6, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50156373 ↗
• MalfunctionJun 18, 2026Break; Leak/Splash

  ON (B)(6) 2026, A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE USING THE TRUE PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY LEAKED AT THE PROXIMAL BALLOON JOINT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545284 ↗
• MalfunctionMar 25, 2026Difficult to Remove; Retraction Problem; Detachment of Device or Device Component

  ON (B)(6) 2026, A 43-YEAR-OLD MALE PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE USING A TRUE CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THEY ATTEMPTED TO REMOVE THE CATHETER, THERE WAS RESISTANCE. IT WAS FURTHER REPORTED THAT THE BALLOON CATHETER ALLEGEDLY GOT SEPARATED FROM ITS INNER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684741 ↗
• MalfunctionJan 27, 2022Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13364906 ↗
• MalfunctionMay 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH FEMORAL ARTERY, THE DEVICE ALLEGEDLY LEAKED AT 2 ATM AT THE PROXIMAL END WHICH WAS CONNECTED TO THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861463 ↗
• MalfunctionMay 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH FEMORAL ARTERY, THE BALLOON ALLEGEDLY LEAKED AT THE PROXIMAL END WHICH CONNECTS TO THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861449 ↗
• MalfunctionMar 1, 2021Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING A PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE BALLOON DID NOT EXPAND PROPERLY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395186 ↗
• MalfunctionJan 9, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0264513 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9572519 ↗
• InjuryAug 1, 2018Deflation Problem; Retraction Problem; Material Rupture; Deflation Problem; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE PTV BALLOON ALLEGEDLY RUPTURED AND COULD NOT BE DEFLATED TO FOLD INTO ITS ORIGINAL SHAPE. IT WAS FURTHER REPORTED THAT THERE WERE ALLEGED DIFFICULTIES RETRACTING THE BALLOON FROM THE PATIENT, WHICH LED TO DETACHMENT OF THE PTV BALLOON IN THE RIGHT COMMON ILIAC ARTERY. A SNARE WAS USED TO ATTEMPT TO REMOVE THE DETACHED BALLOON MATERIAL, BUT WAS UNSUCCESSFUL. THE DETACHED BALLOON MATERIAL WAS LEFT IN THE ARTERY AND A FEMORAL-FEMORAL BYPASS WAS DONE, AS A RESULT OF THE BLOCKED ARTERY. NO FURTHER TREATMENT WAS NEEDED AFTER THE BYPASS PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7741390 ↗
• MalfunctionJun 29, 2017Break; Deflation Problem; Aspiration Issue; Break; Deflation Problem; Aspiration Issue

  IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTIC VALVULOPLASTY PROCEDURE THE BALLOON ALLEGEDLY HAD DIFFICULTY DEFLATING. REPORTEDLY, THE BALLOON ALLEGEDLY WAS ALSO ASPIRATING AIR DURING THE DEFLATION ATTEMPT. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6678002 ↗
• MalfunctionMar 27, 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 6436239 ↗