VascuTrakRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 20 models of VascuTrak by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2016 and Feb 20, 2026 — classified as 5 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (14 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
Reports received per month, all models
Most reported VascuTrak problems
Device problems
- Deflation Problem14
- Material Rupture14
- Break9
- Detachment of Device or Device Component8
- Device-Device Incompatibility3
- Difficult to Remove3
- Material Deformation3
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient23
- No Clinical Signs, Symptoms or Conditions12
- Needle Stick/Puncture3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Injury1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
VascuTrak models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VascuTrak® V184040Catheter, percutaneous, cutting/scoring6 reports
- VascuTrak® V1850150Catheter, percutaneous, cutting/scoring5 reports
- VascuTrak® V1840150Catheter, percutaneous, cutting/scoring4 reports
- VascuTrak® V186040Catheter, percutaneous, cutting/scoring4 reports
- VascuTrak® V1425300Catheter, percutaneous, cutting/scoring2 reports
- VascuTrak® V1840200Catheter, percutaneous, cutting/scoring2 reports
- VascuTrak® V185040Catheter, percutaneous, cutting/scoring2 reports
- VascuTrak® V1850100Catheter, percutaneous, cutting/scoring2 reports
- VascuTrak® V1850120Catheter, percutaneous, cutting/scoring2 reports
- VascuTrak® V1850200Catheter, percutaneous, cutting/scoring2 reports
- VascuTrak® V1420120Catheter, percutaneous, cutting/scoring1 report
- VascuTrak® V142540Catheter, percutaneous, cutting/scoring1 report
- VascuTrak® V1425120Catheter, percutaneous, cutting/scoring1 report
- VascuTrak® V143040Catheter, percutaneous, cutting/scoring1 report
- VascuTrak® V184020Catheter, percutaneous, cutting/scoring1 report
- VascuTrak® V185080Catheter, percutaneous, cutting/scoring1 report
- VascuTrak® V1860150Catheter, percutaneous, cutting/scoring1 report
- VascuTrak® V1860300Catheter, percutaneous, cutting/scoring1 report
- VascuTrak® V184040SCatheter, percutaneous, cutting/scoring1 report
- VascuTrak® V185040SCatheter, percutaneous, cutting/scoring1 report
Recent VascuTrak adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Difficult to Remove; Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE VASCUTRAK BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24398223 ↗MalfunctionMar 10, 2025Material Puncture/Hole; Device Contamination with Chemical or Other Material; Material Puncture/Hole; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY EXPOSED ON THE OUTSIDE OF THE PTA BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21557339 ↗MalfunctionSep 23, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY, IT WAS FOUND THAT THE PTA BALLOON ALLEGEDLY COULD NOT BE REMOVED FROM THE BODY. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS WITHDRAWN FROM THE BODY AFTER AN ALLEGED EXTRACORPOREAL PUNCTURE OF THE BALLOON WITH A MICRO PENETRATING NEEDLE UNDER THE CONTRAST MEDIUM TO RELIEVE THE PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20276688 ↗MalfunctionDec 19, 2022Break; Device Damaged Prior to Use; Device Misassembled During Manufacturing /Shipping; Break; Device Damaged Prior to Use; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT DURING THE PREPARATION OF AN ANGIOPLASTY PROCEDURE, HALF BROKEN GUIDEWIRE WAS ALLEGEDLY OBSERVED ON THE BALLOON TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16002907 ↗MalfunctionNov 30, 2021Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12906185 ↗MalfunctionOct 3, 2021Deflation Problem; Difficult to Flush; Deflation Problem; Difficult to Flush
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY FAILED TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12566686 ↗InjuryMay 5, 2021Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AT THE LOWER LEG, THE CATHETER OF THE PTA BALLOON ALLEGEDLY BROKE. THE PHYSICIAN WAS UNABLE TO SNARE OUT THE BROKEN PIECE FROM THE PATIENT. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11775542 ↗MalfunctionMar 15, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE FEMORAL ARTERY, THE BALLOON ALLEGEDLY FAILED TO INFLATE, UPON RADIOGRAPHIC INSPECTION FLUID LEAK WAS IDENTIFIED. THE BALLOON WAS WITHDRAWN AND WAS NOTED TO HAVE A RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11479275 ↗MalfunctionFeb 24, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA IPISILATERAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY AND AN INFLATION WAS ATTEMPTED, BUT IT FAILED TO INFLATE AGAIN. IT SUCCESSFULLY INFLATED WHEN THE PHYSICIAN LOOSEN THE BALLOON BY HAND. HOWEVER, THE DEVICE ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11371018 ↗MalfunctionJan 22, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11213750 ↗MalfunctionDec 16, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY UNABLE TO LOAD ONTO THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11017294 ↗MalfunctionNov 20, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6ATM. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10873407 ↗MalfunctionOct 23, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL V1425120 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10730916 ↗MalfunctionOct 13, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CALCIFIED LESION IN THE COMMON FEMORAL ARTERY AND SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, RESISTANCE WAS FELT DURING ADVANCING THE CATHETER, AND CONTRAST MEDIUM LEAKAGE WAS FOUND DURING INFLATION. THEN RUPTURE WAS FOUND AFTER REMOVING THE CATHETER AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10673657 ↗InjuryAug 31, 2020Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY UNABLE TO DEFLATE. THE PROCEDURE WAS COMPLETED BY USING A NEEDLE STICK TO DEFLATE THE BALLOON. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Injury
MAUDE report 10474934 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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