Ultraverse 018Recalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 39 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 68
- Deaths reported
- 1
- Injuries reported
- 5
- Recalls
- 0
We found 39 models of Ultraverse 018 by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and Apr 13, 2026 — classified as 1 death, 5 injuries, 62 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (41 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 018 problems
Device problems
- Material Rupture41
- Detachment of Device or Device Component8
- Difficult to Remove8
- Device-Device Incompatibility7
- Break5
- Inflation Problem4
- Material Deformation4
- Deflation Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Consequences Or Impact To Patient18
- No Patient Involvement6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Cardiac Arrest1
- Cardiovascular Dysfunction/Insufficiency1
- Hemorrhage/Blood Loss/Bleeding1
- Injury1
Ultraverse 018 models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ultraverse® 018 U8130630Catheter, angioplasty, peripheral, transluminal8 reports
- Ultraverse® 018 U87554Catheter, angioplasty, peripheral, transluminal5 reports
- Ultraverse® 018 U813034Catheter, angioplasty, peripheral, transluminal4 reports
- Ultraverse® 018 U875410Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 018 U81502H15Catheter, angioplasty, peripheral, transluminal3 reports
- Ultraverse® 018 U81302H22Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U875310Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U87544Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U813054Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U8130522Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U87564Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U8150215Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U81502H30Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U8150315Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U8150322Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U8150530Catheter, angioplasty, peripheral, transluminal2 reports
- Ultraverse® 018 U8130222Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8752H15Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U87534Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U813044Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U875415Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8130415Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U875510Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8130510Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8130515Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U875610Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U875615Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U875622Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8130622Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8130330Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U815028Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8150210Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8150222Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8150230Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U81502H12Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U81502H22Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8150415Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U8150430Catheter, angioplasty, peripheral, transluminal1 report
- Ultraverse® 018 U820084Catheter, angioplasty, peripheral, transluminal1 death1 report
Recent Ultraverse 018 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Inflation Problem; Device Contamination with Chemical or Other Material
On (b)(6)2026, a 48-year-old male patient underwent a percutaneous transluminal angioplasty (PTA) procedure using the Ultraverse 018 balloon catheter. During the procedure, the balloon catheter allegedly unable to inflate and the particles came from inside of 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 24856074 ↗MalfunctionDec 3, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 018 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 23702607 ↗MalfunctionDec 1, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 018 PTA BALLOON. DURING THE PROCEDURE, 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 23679656 ↗MalfunctionNov 20, 2025Break; Break
ON (B)(6) 2025, PRIOR TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 018 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY BROKEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23601889 ↗MalfunctionOct 31, 2025Deflation Problem; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation; Deflation Problem; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE 018 PTA BALLOON. DURING THE PROCEDURE, 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 23435085 ↗MalfunctionSep 2, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 018 PTA BALLOON CATHETER. DURING THE PROCEDURE THE BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929856 ↗MalfunctionJul 22, 2025Material Opacification; Tear, Rip or Hole in Device Packaging; Material Opacification; Tear, Rip or Hole in Device Packaging
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 018 PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE STERILIZATION PACK WAS FOUND TO BE TORN, AND THE PRODUCT IS IN A BROKEN STERILIZED PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563431 ↗MalfunctionJun 16, 2025Crack; Material Deformation; Crack; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 018 PTA BALLOON CATHETER TO TREAT CHRONIC OCCLUSIVE DISEASE OF THE LOWER EXTREMITIES. DURING THE PROCEDURE, THE BALLOON TIP WAS ALLEGEDLY CRACKED DURING INSERTION INTO THE BODY. IT WAS FURTHER REPORTED THAT THE BALLOON TIP IS ABNORMALLY EXPANDED AND THERE WAS A CRACK ON THE GUIDEWIRE HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212223 ↗MalfunctionJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE 018 PTA BALLOON CATHETER VIA COMMON FEMORAL CONTRALATERAL APPROACH. DURING THE PROCEDURE, THE MARKER ON THE CATHETER BALLOON WAS ALLEGEDLY OFF A CENTIMETER OR TWO. IT WAS FURTHER REPORTED THAT THE BALLOON INFLATED BEYOND THE MARKER. BALLOON WAS REMOVED, AND ANGIOGRAM WAS PERFORMED TO VERIFY NO INJURY TO THE VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201310 ↗MalfunctionApr 2, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749825 ↗MalfunctionMar 31, 2025Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY GOT STUCK AND UNABLE TO TRACK TO THE DESIRED LOCATION FOR INFLATION. IT WAS FURTHER REPORTED THAT THERE WAS AN ISSUE WHEN TRYING TO READVANCE THE SHEATH. REPORTEDLY, IT WAS VERY TIGHT WHILE REMOVING THE DEVICE THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21729325 ↗MalfunctionJan 31, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING TO AN ANGIOPLASTY PROCEDURE IN SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT AROUND 6 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21281526 ↗MalfunctionDec 25, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY VIA LEFT COMMON ILIAC ARTERY, AFTER DILATATION, IT WAS FOUND THAT THE BALLOON ALLEGEDLY COULD NOT BE RETRIEVED, AND THE BALLOON WAS WITHDRAWN FROM THE BODY AFTER EXTRACORPOREAL PUNCTURE OF THE BALLOON WITH A MICRO PENETRATING NEEDLE UNDER THE CONTRAST MEDIUM WAS PERFORMED TO RELIEVE THE PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21014823 ↗MalfunctionNov 26, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, 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 20785884 ↗MalfunctionOct 28, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20542704 ↗
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