TRUE FLOW TF0183511Recalls & reported problems
Bard Peripheral Vascular, Inc. · TRUE™ FLOW Valvuloplasty Perfusion Catheter, 18 mm x 3.5 cm, 110 cm catheter · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741097645), received between May 25, 2017 and Aug 3, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Device-Device Incompatibility1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗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 ↗MalfunctionMay 25, 2017Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
IT WAS REPORTED THAT DURING AN AORTIC VALVULOPLASTY PROCEDURE AN ALLEGED LEAK WAS FOUND AT THE GLUE JOINT OF THE BALLOON CATHETER ON THE FIRST INFLATION ATTEMPT. REPORTEDLY, THERE WAS NO ISSUE RETRACTING THE BALLOON THROUGH THE SHEATH. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6592966 ↗
Other Balloon aortic valvuloplasty devices
- TRUE DILATATION 0224512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty23 reports
- TRUE DILATATION 0204511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty21 reports
- TRUE DILATATION 0244512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty2 deaths19 reports
- TRUE DILATATION 0184511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty12 reports
- TRUE DILATATION 0264513Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty11 reports
- TRUE DILATATION 0234512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty1 death10 reports
- TRUE DILATATION 0214512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty10 reports
- TRUE FLOW TF0203511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.