Ultraverse 014Recalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 110
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 36 models of Ultraverse 014 by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2016 and Dec 3, 2025 — classified as 7 injuries, 103 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (43 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 014 problems
Device problems
- Material Rupture43
- Detachment of Device or Device Component41
- Break25
- Difficult to Remove11
- Material Deformation10
- Device-Device Incompatibility9
- Peeled/Delaminated8
- Packaging Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient30
- No Patient Involvement24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body In Patient1
- Injury1
- Perforation1
- Perforation of Vessels1
Ultraverse 014 models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ultraverse® 014 U41502H22Catheter, angioplasty, peripheral, transluminal22 reports
- Ultraverse® 014 U4150222Catheter, angioplasty, peripheral, transluminal9 reports
- Ultraverse® 014 U41502H30Catheter, angioplasty, peripheral, transluminal9 reports
- Ultraverse® 014 U4150230Catheter, angioplasty, peripheral, transluminal8 reports
- Ultraverse® 014 U4150330Catheter, angioplasty, peripheral, transluminal7 reports
- Ultraverse® 014 U41502H15Catheter, angioplasty, peripheral, transluminal5 reports
- Ultraverse® 014 U4150322Catheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® 014 U4150510Catheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® 014 U410024Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 014 U4150215Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 014 U415034Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 014 U41502H12Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 014 U4150310Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 014 U4150410Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 014 U415054Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 014 U41501H4Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 014 U41501H12Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 014 U4150422Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 014 U4150515Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 014 U41001H2Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U415024Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U415028Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U4100210Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U4150212Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U4100222Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U41502H4Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U41502H10Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U415038Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U4150315Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U415044Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U415058Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U4150512Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U415022Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U41503H22Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U4150430Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 014 U4150530Catheter, angioplasty, peripheral, transluminal1 report
Recent Ultraverse 014 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 014 PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURE. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULTY IN RETRACTING THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23702145 ↗MalfunctionNov 26, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656413 ↗MalfunctionOct 28, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated
ON (B)(6) 2025, A PATIENT PREPPED FOR AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 014 PTA BALLOON. PRIOR TO THE PROCEDURE, THE BALLOON ALLEGEDLY DISINTEGRATED WHILE PREPPING. IT WAS FURTHER REPORTED THAT THE FRAGMENTS WERE DETACHED AND HANGING FROM THE END OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404925 ↗MalfunctionOct 22, 2025Difficult to Remove; Device-Device Incompatibility; Material Deformation; Difficult to Remove; Device-Device Incompatibility; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 014 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY CORRUGATED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE AND THE INTRODUCER WERE DRAGGED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23359799 ↗MalfunctionSep 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD SYRINGE 10ML SALINE FILL CHINA SP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, FOLLOWING COMPLETION OF INTRAVENOUS MEDICATION INFUSION, THE CENTRAL VENOUS CATHETER WAS ROUTINELY SEALED USING A PRE-FILLED CATHETER FLUSHING DEVICE. DURING THE INJECTION PROCESS, LEAKAGE OCCURRED AT THE PRE-FILLED PISTON. THE PRE-FILLED CATHETER FLUSHING DEVICE WAS IMMEDIATELY REPLACED FOR THE PATIENT, AND THE SEALING PROCEDURE WAS REPEATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23091912 ↗MalfunctionAug 13, 2025Break; Difficult to Remove; Material Rupture; Stretched; Break; Difficult to Remove; Material Rupture; Stretched
ON (B)(6) 2025, THE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN ANTERIOR TIBIAL ARTERY USING PTA BALLOON, DURING THE PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY GOT RUPTURED. IT WAS FURTHER REPORTED THAT THERE WAS A SLIGHT RESISTANCE IN REMOVING THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22791253 ↗MalfunctionJul 9, 2025Deflation Problem; Peeled/Delaminated; Deflation Problem; Peeled/Delaminated
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 014 PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE BALLOON WAS VERY SLOW TO DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22455550 ↗MalfunctionApr 14, 2025Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Material Deformation; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER WHILE TRYING TO REMOVE THE BALLOON PROTECTOR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21832304 ↗MalfunctionMar 3, 2025Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent; Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT IT WAS ALLEGEDLY PUMPED BACK UP WITH SALINE ONLY, AFTER SECOND SALINE INJECTION, THEY WERE ABLE TO DEFLATE BALLOON ENOUGH TO REMOVE IT. REPORTEDLY, THE PTA BALLOON WAS ALLEGEDLY TWISTED DISTALLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21511001 ↗MalfunctionDec 26, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21018301 ↗MalfunctionJul 31, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERIFICIAL FEMORAL ARTERY LESION, THE PTA BALLOON WAS 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 19869801 ↗MalfunctionJun 28, 2024Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY PULLED APART FROM THE CATHETER AND BROKE. FURTHER IT WAS REPORTED THAT THE COMPONENT WAS STILL TOGETHER AND ATTACHED TO THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19633646 ↗MalfunctionApr 18, 2024Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A VERY CALCIFIED VESSEL, THE PTA BALLOON ALLEGEDLY DETACHED INSIDE OF THE PATIENT AND A SNARE WAS USED TO REMOVE THE DETACHED SEGMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19131556 ↗MalfunctionFeb 16, 2024Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BROKE THROUGH THE SHEATH IN THE PROCESS OF DECOMPRESSING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18719208 ↗MalfunctionFeb 2, 2024Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE VIA FEMORAL ARTERY, RESISTANCE WAS ALLEGEDLY FELT WHILE REMOVING PROTECTIVE SHEATH OF BALLOON AFTER REMOVING FROM THE LOOP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629387 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page