TRUE FLOW TF0223512Recalls & reported problems
Bard Peripheral Vascular, Inc. · TRUE™ FLOW Valvuloplasty Perfusion Catheter, 22 mm x 3.5 cm, 110 cm catheter · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741097669), received between Feb 9, 2017 and Apr 22, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (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
- Peeled/Delaminated2
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Difficult to Insert1
- Flushing Problem1
- Inflation Problem1
- Leak/Splash1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- No Patient Involvement2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 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 ↗MalfunctionApr 9, 2018Peeled/Delaminated; Detachment of Device or Device Component; Unintended Movement; Peeled/Delaminated; Detachment of Device or Device Component; Unintended Movement
IT WAS REPORTED THAT DURING A TAVR PROCEDURE THE OUTER FIBER SHELL OF THE BALLOON ALLEGEDLY BEGAN TO PARTIALLY PEEL OFF DURING RETRACTION THROUGH THE SHEATH. THE BALLOON WAS ABLE TO BE SUCCESSFULLY RETRACTED 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 7409963 ↗MalfunctionFeb 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN AORTIC VALVULOPLASTY, THE X-RAY MARKERS ON THE BALLOON WERE ALLEGEDLY NOT VISIBLE WHILE ATTEMPTING TO POSITION THE BALLOON. REPORTEDLY, THE BALLOON WAS SUCCESSFULLY RETRACTED OUT OF THE PATIENT AND THE HEALTH CARE PROVIDER CHECKED FOR MARKERS BUT NO MARKERS WERE VISIBLE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6314082 ↗
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.