Ultraverse RXRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 56 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 536
- Deaths reported
- 1
- Injuries reported
- 15
- Recalls
- 0
We found 56 models of Ultraverse RX by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 536 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2016 and Aug 17, 2026 — classified as 1 death, 15 injuries, 520 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (362 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 RX problems
Device problems
- Material Rupture362
- Material Deformation82
- Detachment of Device or Device Component69
- Failure to Advance54
- Break43
- Device-Device Incompatibility24
- Difficult to Remove24
- Deflation Problem14
Patient problems
- No Clinical Signs, Symptoms or Conditions370
- No Consequences Or Impact To Patient144
- No Patient Involvement9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- No Known Impact Or Consequence To Patient2
- Death1
- Device Embedded In Tissue or Plaque1
- Injury1
Ultraverse RX models
56 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ultraverse® RX U415044RXCatheter, angioplasty, peripheral, transluminal38 reports
- Ultraverse® RX U415054RXCatheter, angioplasty, peripheral, transluminal33 reports
- Ultraverse® RX U4150230RXCatheter, angioplasty, peripheral, transluminal32 reports
- Ultraverse® RX U415024RXCatheter, angioplasty, peripheral, transluminal30 reports
- Ultraverse® RX U415064RXCatheter, angioplasty, peripheral, transluminal27 reports
- Ultraverse® RX U415034RXCatheter, angioplasty, peripheral, transluminal26 reports
- Ultraverse® RX U41501H12RXCatheter, angioplasty, peripheral, transluminal22 reports
- Ultraverse® RX U4150310RXCatheter, angioplasty, peripheral, transluminal22 reports
- Ultraverse® RX U4150515RXCatheter, angioplasty, peripheral, transluminal20 reports
- Ultraverse® RX U4150530RXCatheter, angioplasty, peripheral, transluminal20 reports
- Ultraverse® RX U41502H30RXCatheter, angioplasty, peripheral, transluminal19 reports
- Ultraverse® RX U415074RXCatheter, angioplasty, peripheral, transluminal18 reports
- Ultraverse® RX U4150510RXCatheter, angioplasty, peripheral, transluminal16 reports
- Ultraverse® RX U41501Q1HRXCatheter, angioplasty, peripheral, transluminal15 reports
- Ultraverse® RX U4150210RXCatheter, angioplasty, peripheral, transluminal14 reports
- Ultraverse® RX U4150215RXCatheter, angioplasty, peripheral, transluminal13 reports
- Ultraverse® RX U4150225RXCatheter, angioplasty, peripheral, transluminal13 reports
- Ultraverse® RX U4150410RXCatheter, angioplasty, peripheral, transluminal13 reports
- Ultraverse® RX U4150315RXCatheter, angioplasty, peripheral, transluminal12 reports
- Ultraverse® RX U4150430RXCatheter, angioplasty, peripheral, transluminal12 reports
- Ultraverse® RX U41502H4RXCatheter, angioplasty, peripheral, transluminal10 reports
- Ultraverse® RX U4150525RXCatheter, angioplasty, peripheral, transluminal10 reports
- Ultraverse® RX U41502H15RXCatheter, angioplasty, peripheral, transluminal9 reports
- Ultraverse® RX U4150415RXCatheter, angioplasty, peripheral, transluminal9 reports
- Ultraverse® RX U4150520RXCatheter, angioplasty, peripheral, transluminal9 reports
- Ultraverse® RX U41502H20RXCatheter, angioplasty, peripheral, transluminal8 reports
- Ultraverse® RX U41502H10RXCatheter, angioplasty, peripheral, transluminal7 reports
- Ultraverse® RX U4150330RXCatheter, angioplasty, peripheral, transluminal7 reports
- Ultraverse® RX U41502H25RXCatheter, angioplasty, peripheral, transluminal6 reports
- Ultraverse® RX U4150425RXCatheter, angioplasty, peripheral, transluminal6 reports
- Ultraverse® RX U41501H1HRXCatheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® RX U4200210RXCatheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® RX U4200220RXCatheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® RX U4200330RXCatheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® RX U420024RXCatheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® RX U42002H20RXCatheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® RX U42002H30RXCatheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® RX U415038RXCatheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® RX U42001H2RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U42001H4RXCatheter, angioplasty, peripheral, transluminal1 death1 report
- Ultraverse® RX U42001H8RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U42001H12RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U415028RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U4150212RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U4200215RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U4200230RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U42002H10RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U415032RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U420038RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U4200310RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U4150320RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U42003H20RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U415048RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U420048RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U415052RXCatheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® RX U4200510RXCatheter, angioplasty, peripheral, transluminal1 report
Recent Ultraverse RX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50272209 ↗MalfunctionAug 10, 2026Material Rupture
On (b)(6), 2026, a patient underwent a percutaneous transluminal angioplasty procedure using the Ultraverse RX balloon catheter. During the procedure, the balloon catheter 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 50190754 ↗MalfunctionAug 10, 2026Material Rupture
On (b)(6)2026, a patient underwent a percutaneous transluminal angioplasty procedure using the Ultraverse RX balloon catheter. During the procedure, the balloon catheter was allegedly ruptured. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50190638 ↗MalfunctionApr 20, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER 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 24921796 ↗MalfunctionApr 17, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER 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 24908634 ↗MalfunctionApr 13, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX 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 24854711 ↗MalfunctionApr 3, 2026Difficult to Insert; Device-Device Incompatibility; Material Deformation
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL ANTEGRADE APPROACH USING THE ULTRAVERSE RX. PRIOR TO THE PROCEDURE, THE SHAFT ALLEGEDLY KINKED AND WOULD NOT PASS THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781198 ↗MalfunctionMar 26, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX 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 24695494 ↗MalfunctionMar 26, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX 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 24695493 ↗MalfunctionMar 25, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL APPROACH USING THE ULTRAVERSE RX PTA BALLOON. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON 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 24684178 ↗MalfunctionMar 19, 2026Deflation Problem; Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE ULTRAVERSE RX BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY FAILED TO FULLY DEFLATE, AND WHEN REMOVAL WAS ATTEMPTED, THE CATHETER BALLOON WAS RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24635975 ↗MalfunctionMar 10, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX 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 24555037 ↗MalfunctionFeb 17, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX 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 24363360 ↗MalfunctionFeb 17, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX 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 24363098 ↗MalfunctionJan 29, 2026Material Rupture
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE ULTRAVERSE RX BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206853 ↗
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
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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