TRUE FLOWRecalls & reported problems across all models

We found 4 models of TRUE FLOW by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2016 and Aug 3, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TRUE FLOW problems

TRUE FLOW models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TRUE FLOW TF0203511

  Balloon aortic valvuloplasty
  10 reports
• TRUE FLOW TF0223512

  Balloon aortic valvuloplasty
  6 reports
• TRUE FLOW TF0243514

  Balloon aortic valvuloplasty
  5 reports
• TRUE FLOW TF0183511

  Balloon aortic valvuloplasty
  3 reports

Recent TRUE FLOW adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114816 ↗
• 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 ↗
• MalfunctionApr 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING TO A VALVULOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DID NOT INFLATE. IT WAS FURTHER REPORTED THAT THE CONTRAST COMING THROUGH THE SHAFT BUT DID NOT GO THROUGH THE BACK OF THE BALLOON SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884727 ↗
• 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 ↗
• MalfunctionApr 1, 2021Flushing Problem; Inflation Problem; Material Puncture/Hole; Flushing Problem; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO THE TREATMENT THE CATHETER ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY FAILED TO FLUSH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600654 ↗
• 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 ↗
• MalfunctionJan 15, 2019Difficult to Insert; Peeled/Delaminated; Difficult to Insert; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A BALLOON AORTIC VALVULOPLASTY, THE BALLOON ALLEGEDLY HAD DIFFICULTY BEING INSERTED THROUGH THE SHEATH. ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8249445 ↗
• 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 ↗
• 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 ADVANCEMENT. IT WAS FURTHER REPORTED THAT AFTER SIGNIFICANT RESISTANCE THE BALLOON VALVULOPLASTY CATHETER WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8118514 ↗
• MalfunctionNov 28, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT UPON REMOVAL FROM THE PACKAGING, A KINK WAS OBSERVED ON THE CATHETER OF THE PTV BALLOON. ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8113502 ↗

Other Bard Peripheral Vascular, Inc. products

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• MAGNUM19 models · 571 reports · 1 recall
• Conquest32 models · 560 reports
• Ultraverse RX56 models · 536 reports
• Fluency Endovascular Stent Graft51 models · 532 reports
• Atlas Gold33 models · 427 reports
• Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports