TRUE DILATATION 0224512Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741091001), received between Jan 12, 2017 and May 13, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Aspiration Issue” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A VALVULOPLASTY PROCEDURE USING THE TRUE BALLOON DILATATION CATHETER. DURING THE PROCEDURE, THE PROXIMAL PART OF THE BALLOON ALLEGEDLY LEAKED DUE TO PINHOLE RUPTURE AT 4 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157638 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A VALVULOPLASTY PROCEDURE, AIR WAS VENTING IN CONTINUOUSLY RESULTING IN LEAKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399410 ↗
• MalfunctionDec 27, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO VALVULOPLASTY PROCEDURE, ALLEGEDLY THERE WAS LEAKAGE IN THE CONNECTION BETWEEN THE HUB AND THE SHAFT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21024649 ↗
• MalfunctionNov 12, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY COULD NOT BE DEFLATED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664293 ↗
• InjuryAug 30, 2022Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING VALVULOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AND DETACHED FROM SHAFT. IT WAS FURTHER REPORTED THAT MULTIPLE ATTEMPTS MADE TO REMOVE DETACHED MATERIAL. REPORTEDLY THE DETACHED SEGMENT REMAINED IN THE RIGHT EXTERNAL ILIAC ARTERY CAUSING ARTERIAL INJURY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15318244 ↗
• MalfunctionApr 15, 2020Leak/Splash; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0224512 VALVULOPLASTY BALLOON CATHETER ALLEGEDLY EXPERIENCED A LEAK. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE 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 9965733 ↗
• InjuryOct 2, 2019Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE AORTIC VALVE, THE PTA BALLOON ALLEGEDLY GOT STUCK INSIDE THE SHEATH DURING RETRACTION. IT WAS FURTHER REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED TO CUT DOWN AND REMOVE THE BALLOON FROM THE PATIENT. REPORTEDLY, IT IS UNKNOWN HOW THE ANGIOPLASTY PROCEDURE WAS COMPLETED. THE STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 9148363 ↗
• MalfunctionNov 29, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN AORTIC VALVULOPLASTY PROCEDURE, THE BALLOON VALVULOPLASTY CATHETER ALLEGEDLY GOT CAUGHT ON THE GUIDEWIRE DURING REMOVAL FROM THE PATIENT. THE BALLOON AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. IT WAS FURTHER REPORTED THAT AFTER THE PROCEDURE, SIGNIFICANT RESISTANCE WAS FELT IN ORDER TO REMOVE THE BALLOON FROM THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118516 ↗
• MalfunctionNov 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRIOR TO A VALVULOPLASTY PROCEDURE, THE PTV BALLOON ALLEGEDLY RUPTURED DURING A TEST INFLATION. ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8071943 ↗
• MalfunctionMay 7, 2018Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT THE VALVULOPLASTY BALLOON ALLEGEDLY WOULD NOT HOLD THE PRESSURE THROUGHOUT INFLATION. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED FROM THE PATIENT AND AN ATTEMPT TO INFLATE IT ON THE BACK TABLE ALLEGEDLY DISCOVERED A PIN HOLE RUPTURE AT THE DISTAL PORTION OF THE BALLOON. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER VALVULOPLASTY BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7492609 ↗
• MalfunctionApr 3, 2018Aspiration Issue; Aspiration Issue

  IT WAS REPORTED THAT DURING PREPARATION FOR A TAVI PROCEDURE, THE VALVULOPLASTY BALLOON ALLEGEDLY COULD NOT BE ASPIRATED WITH A LUER LOCK SYRINGE. THE BALLOON WAS EXCHANGED FOR ANOTHER TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7394477 ↗
• MalfunctionApr 3, 2018Aspiration Issue; Aspiration Issue

  IT WAS REPORTED THAT DURING PREPARATION FOR A TAVI PROCEDURE, THE VALVULOPLASTY BALLOON ALLEGEDLY COULD NOT BE ASPIRATED WITH A LUER LOCK SYRINGE. THE BALLOON WAS EXCHANGED FOR ANOTHER TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7392938 ↗
• InjuryDec 27, 2017Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT POST DILATATION OF A 26MM TAVI, DURING RETRACTION THROUGH A 14 FR SHEATH, THE VALVULOPLASTY BALLOON ALLEGEDLY WOULD NOT RETRACT INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE SHEATH AND CATHETER WERE REMOVED TOGETHER AS A SINGLE UNIT RESULTING IN ALLEGED TRAUMA AT THE FEMORAL ARTERY ACCESS SITE, REQUIRING ADDITIONAL BALLOON ANGIOPLASTY TO TAMPONADE THE RESULTANT LEAK. PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7149104 ↗
• MalfunctionDec 10, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A TAVI PROCEDURE, THE VALVULOPLASTY BALLOON ALLEGEDLY COULD NOT BE DEFLATED WITH A SYRINGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7102611 ↗
• MalfunctionDec 6, 2017Leak/Splash; Aspiration Issue; Leak/Splash; Aspiration Issue

  IT WAS REPORTED THAT DURING AN AORTIC VALVULOPLASTY PROCEDURE AN ALLEGED AIR BUBBLE WAS FOUND INSIDE THE BALLOON DURING INFLATION. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. A NEW SYRINGE AND STOPCOCK WAS USED BUT THE SAME ISSUE OCCURRED. A NEW BALLOON WAS PREPPED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088276 ↗
• MalfunctionOct 6, 2017Difficult to Insert; Retraction Problem; Difficult to Insert; Retraction Problem

  IT WAS REPORTED THAT AFTER A BALLOON AORTIC VALVULOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD DIFFICULTIES PASS THROUGH THE 12FR SHEATH BUT EVENTUALLY WOULD NOT RETRACT THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE VALVULOPLASTY BALLOON CATHETER AND SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT. PATIENT STATUS IS UNKNOWN AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6921005 ↗
• MalfunctionOct 6, 2017Difficult to Insert; Retraction Problem; Difficult to Insert; Retraction Problem

  IT WAS REPORTED THAT AFTER A BALLOON AORTIC VALVULOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD DIFFICULTIES PASSING THRU THE 12FR SHEATH BUT EVENTUALLY WOULD NOT RETRACT THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE VALVULOPLASTY BALLOON CATHETER AND SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT. PATIENT STATUS IS UNKNOWN AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6919639 ↗
• MalfunctionAug 15, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT THE BALLOON ALLEGEDLY WOULD NOT INFLATE PAST 5 ATM. THE HEALTH CARE PROVIDER DEFLATED AND REMOVED THE BALLOON SUCCESSFULLY FROM THE PATIENT. UPON FURTHER INSPECTION OF THE BALLOON ON THE BACK TABLE, THE HEALTH CARE PROVIDER FOUND A PINHOLE RUPTURE NEAR THE PROXIMAL END OF THE BALLOON. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6795203 ↗
• MalfunctionJul 10, 2017Aspiration Issue; Aspiration Issue

  IT WAS REPORTED THAT THE VALVULOPLASTY BALLOON CATHETER ALLEGEDLY ASPIRATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6699704 ↗
• MalfunctionMay 30, 2017Peeled/Delaminated; Aspiration Issue; Peeled/Delaminated; Aspiration Issue

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

  Patient problems: No Patient Involvement

  MAUDE report 6599951 ↗
• MalfunctionMar 21, 2017Aspiration Issue; Aspiration Issue

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

  Patient problems: No Patient Involvement

  MAUDE report 6420624 ↗
• MalfunctionFeb 24, 2017Leak/Splash; Aspiration Issue; Leak/Splash; Aspiration Issue

  IT WAS REPORTED THAT THE VALVULOPLASTY BALLOON ALLEGEDLY ASPIRATED WHILE PULLING NEGATIVE PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 6358768 ↗
• MalfunctionJan 12, 2017Crack; Crack

  IT WAS REPORTED THAT UPON REMOVING THE DEVICE FROM THE PROTECTIVE SHEATH AN ALLEGED CRACK WAS OBSERVED ON THE PROXIMAL BALLOON HUB. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6247915 ↗