Ultraverse 035 PTA Dilatation CatheterRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 92 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 393
- Deaths reported
- 1
- Injuries reported
- 45
- Recalls
- 0
We found 92 models of Ultraverse 035 PTA Dilatation Catheter by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 393 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2016 and Apr 20, 2026 — classified as 1 death, 45 injuries, 347 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (223 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 Ultraverse 035 PTA Dilatation Catheter problems
Device problems
- Material Rupture223
- Detachment of Device or Device Component97
- Break57
- Difficult to Remove57
- Retraction Problem50
- Leak/Splash43
- Device-Device Incompatibility26
- Material Deformation23
Patient problems
- No Clinical Signs, Symptoms or Conditions217
- No Consequences Or Impact To Patient122
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- No Patient Involvement14
- No Known Impact Or Consequence To Patient10
- Injury7
- Foreign Body In Patient5
- Vascular Dissection4
Ultraverse 035 PTA Dilatation Catheter models
92 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ultraverse® 035 PTA Dilatation Catheter U357564Catheter, angioplasty, peripheral, transluminal32 reports
- Ultraverse® 035 PTA Dilatation Catheter U357584Catheter, angioplasty, peripheral, transluminal31 reports
- Ultraverse® 035 PTA Dilatation Catheter U357574Catheter, angioplasty, peripheral, transluminal25 reports
- Ultraverse® 035 PTA Dilatation Catheter U357554Catheter, angioplasty, peripheral, transluminal23 reports
- Ultraverse® 035 PTA Dilatation Catheter U3575104Catheter, angioplasty, peripheral, transluminal14 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130415Catheter, angioplasty, peripheral, transluminal12 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130610Catheter, angioplasty, peripheral, transluminal12 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513084Catheter, angioplasty, peripheral, transluminal12 reports
- Ultraverse® 035 PTA Dilatation Catheter U357544Catheter, angioplasty, peripheral, transluminal11 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130128Catheter, angioplasty, peripheral, transluminal11 reports
- Ultraverse® 035 PTA Dilatation Catheter U357588Catheter, angioplasty, peripheral, transluminal8 reports
- Ultraverse® 035 PTA Dilatation Catheter U357594Catheter, angioplasty, peripheral, transluminal8 reports
- Ultraverse® 035 PTA Dilatation Catheter U3575610Catheter, angioplasty, peripheral, transluminal7 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130630Catheter, angioplasty, peripheral, transluminal7 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513086Catheter, angioplasty, peripheral, transluminal7 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130515Catheter, angioplasty, peripheral, transluminal6 reports
- Ultraverse® 035 PTA Dilatation Catheter U3575615Catheter, angioplasty, peripheral, transluminal6 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513066Catheter, angioplasty, peripheral, transluminal6 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513076Catheter, angioplasty, peripheral, transluminal6 reports
- Ultraverse® 035 PTA Dilatation Catheter U35751010Catheter, angioplasty, peripheral, transluminal6 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130104Catheter, angioplasty, peripheral, transluminal6 reports
- Ultraverse® 035 PTA Dilatation Catheter U3575510Catheter, angioplasty, peripheral, transluminal5 reports
- Ultraverse® 035 PTA Dilatation Catheter U357568Catheter, angioplasty, peripheral, transluminal5 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130615Catheter, angioplasty, peripheral, transluminal5 reports
- Ultraverse® 035 PTA Dilatation Catheter U357586Catheter, angioplasty, peripheral, transluminal5 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513054Catheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130520Catheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513064Catheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® 035 PTA Dilatation Catheter U3575106Catheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130106Catheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® 035 PTA Dilatation Catheter U357542Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U354054Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U3575515Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130530Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U357566Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513068Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130625Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513074Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U357598Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U351301210Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130312Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U354044Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513044Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U357556Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U3513056Catheter, angioplasty, peripheral, transluminal1 death2 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130510Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U354064Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U357562Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U3575630Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U3575710Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130815Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U357592Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U3575124Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130124Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U35130126Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 035 PTA Dilatation Catheter U357532Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U357534Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3575320Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513032Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513034Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513038Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130310Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130315Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130330Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U357546Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3575410Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513046Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130412Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3575530Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513052Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513058Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130512Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3575612Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3575620Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513062Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130620Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U357572Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U357576Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U357578Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3575712Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513078Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130720Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U357582Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513088Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130810Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130812Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513094Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3513098Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3575102Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U35130108Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U351301010Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 035 PTA Dilatation Catheter U3575128Catheter, angioplasty, peripheral, transluminal1 report
Recent Ultraverse 035 PTA Dilatation Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Deflation Problem; Difficult to Insert; Device-Device Incompatibility
ON (B)(6) 2026, THE PATIENT WAS PREPPED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING AN ULTRAVERSE 035 BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE BALLOON CATHETER WAS REPORTEDLY UNABLE TO BE INSERTED. FURTHER, DEFLATION PROBLEM WAS IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24921679 ↗MalfunctionApr 15, 2026Leak/Splash; Device Dislodged or Dislocated
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 035 PTA BALLOON. DURING THE PROCEDURE, IT WAS NOTICED THAT FLUID LEAKAGE WAS OBSERVED AT THE DISTAL END OF 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 24880629 ↗MalfunctionMar 25, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE VIA CONTRALATERAL APPROACH USING THE ULTRAVERSE 035 PTA BALLOON. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684743 ↗InjuryFeb 16, 2026Deflation Problem; Difficult to Remove
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO DEFLATE AND DIFFICULTY TO REMOVE FROM THE SHEATH. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Perforation of Vessels
MAUDE report 24342213 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL OF A NON-COMMERCIALLY AVAILABLE DEVICE, BD LOW PROFILE VASCULAR COVERED STENT (LPVCS). THE SUBJECT UNDERWENT TARGET LESION INTERVENTION ON THE SUPERFICIAL FEMORAL ARTERY IN THE LEFT LIMB USING A COMMERCIALLY AVAILABLE ULTRAVERSE BALLOON WHEN AN ADVERSE EVENT OF VESSEL DISSECTION OCCURRED. THE SEVERITY AND ADVERSE EVENT RELATIVITY WITH THE DEVICE OR PROCEDURE WERE NOT REPORTED. THE LESION WAS STENTED.
Patient problems: Vascular Dissection
MAUDE report 24197606 ↗MalfunctionDec 24, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23886154 ↗MalfunctionDec 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON (B)(6) 2025, PRIOR TO A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. IT WAS FOUND PRIOR TO THE PROCEDURE; BALLOON ALLEGEDLY SHAFT CUTTED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835893 ↗MalfunctionDec 3, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23702609 ↗MalfunctionNov 25, 2025Deflation Problem; Leak/Splash; Difficult to Remove; Deflation Problem; Leak/Splash; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 035 PTA BALLOON, DURING THE PROCEDURE THE CATHETER HUB JOINT ALLEGEDLY LEAKED AND FURTHER IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO FULLY DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23641927 ↗MalfunctionNov 3, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23448823 ↗MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN FOR USING FISTULA ANGIOPLASTY USING ULTRAVERSE 035 THE PTA BALLOON. PRIOR TO THE PROCEDURE, THE BALLOON WAS ALLEGEDLY FOUND TO BE BROKEN INTO TWO PARTS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337505 ↗MalfunctionOct 16, 2025Leak/Splash; Device Dislodged or Dislocated; Leak/Splash; Device Dislodged or Dislocated
ON (B)(6) 2025, THE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY USING THE ULTRAVERSE 035 PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY DOES NOT INFLATE. IT WAS FURTHER REPORTED THAT THE SALINE SOLUTION LEAK WAS LOCATED AT THE JOINT BETWEEN THE CATHETER CARRIER AND THE HUB WITH THE LUER-LOCK PORTS. THE STRAIN RELIEF WAS OBSERVED TO BE SEPARATED FROM THE Y-BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23307855 ↗MalfunctionSep 25, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23142887 ↗MalfunctionSep 24, 2025Inflation Problem; Material Rupture; Material Deformation; Inflation Problem; Material Rupture; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 035 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY UNABLE TO INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23130508 ↗MalfunctionSep 24, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 035 PTA BALLOON TO THE CALCIFIED LESION IN THE LEFT EIA USING A CROSSOVER APPROACH. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY RUPTURED WHEN EXPANDED AT NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23130234 ↗
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
- Dorado49 models · 387 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page