Ultraverse® RX U4150230RXRecalls & reported problems
Bard Peripheral Vascular, Inc. · Ultraverse® RX PTA Dilatation Catheter 2 mm x 300 mm, 150 cm Catheter · Class 2
All models of Ultraverse RX (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Ultraverse RX balloon catheter is used to open narrowed blood vessels, including in leg and groin arteries. Its 32 reports mostly describe the balloon rupturing during the procedure, sometimes below the expected pressure, plus kinking, snapping, and the shaft separating. There are no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741056383), received between Jan 3, 2017 and Mar 26, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (19 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture19
- Material Deformation12
- Failure to Advance6
- Break3
- Detachment of Device or Device Component3
- Device-Device Incompatibility3
- Difficult to Insert1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Consequences Or Impact To Patient9
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionNov 25, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, 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 23641582 ↗MalfunctionOct 22, 2025Material Rupture; Material Deformation; Material Split, Cut or Torn; Material Rupture; Material Deformation; Material Split, Cut or Torn
ON (B)(6) 2025, A PATIENT WAS UNDERGOING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING AN ULTRAVERSE RX BALLOON ON TARGET LESION BELOW THE KNEE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY HAD PINHOLE RUPTURE AT 6 ATM DUE TO CALCIFICATION. IT WAS FURTHER REPORTED THAT 2.5-300 WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356550 ↗MalfunctionJun 17, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX. DURING THE PROCEDURE THE PTA BALLOON ALLEGEDLY RUPTURED BELOW NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22217517 ↗MalfunctionJun 13, 2025Material Rupture; Material Rupture
A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED DURING THE FIRST EXPANSION AT 8 ATMOSPHERES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201185 ↗MalfunctionMay 26, 2025Material Deformation; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE FOR THE SAME-SIDED BELOW KNEE TREATMENT VIA GROIN SITE USING THE ULTRAVERSE RX PTA BALLOON CATHETER. DURING THE PROCEDURE, THE SHAFT WAS ALLEGEDLY KINKED DUE TO STRONG BENDING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22082993 ↗MalfunctionMar 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA SHAFT ALLEGEDLY SEPARATED DURING DELIVERY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21729042 ↗MalfunctionFeb 18, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21393583 ↗MalfunctionDec 13, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A CALCIFIED LESION, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 6 ATM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20922056 ↗MalfunctionNov 12, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED ANTERIOR TIBIAL ARTERY LESION VIA THE SAME-SIDE APPROACH, THE PTA BALLOON TIP ALLEGEDLY CURLED. IT WAS FURTHER REPORTED THAT ALLEGEDLY THE BALLOON DID NOT PASS THROUGH THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20661978 ↗MalfunctionJul 25, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY LESION ON THE SAME SIDE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 7 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19824480 ↗MalfunctionJun 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE WITH IPSILATERAL PROGRESSIVE APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 4 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19622016 ↗MalfunctionApr 1, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011508 ↗MalfunctionOct 17, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A TARGET LESION BELOW THE KNEE IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17949630 ↗MalfunctionSep 29, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY KINKED UPON PUSHING HARD. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17841276 ↗MalfunctionApr 25, 2023Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE BELOW THE KNEE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT THE TIP ALLEGEDLY BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16806270 ↗MalfunctionApr 19, 2023Difficult to Insert; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Difficult to Insert; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE CATHETER ALLEGEDLY BENT EASILY AND IT FAILED TO BE ADVANCED THROUGH THE SHEATH. 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 16768580 ↗MalfunctionFeb 11, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION BELOW THE KNEE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO CROSS THE LESION. IT WAS FURTHER REPORTED THAT THE CATHETER SHAFT WAS ALLEGEDLY KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13511945 ↗MalfunctionSep 28, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT OF THE PTA BALLOON WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12539718 ↗MalfunctionApr 27, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER SHAFT WAS ALLEGEDLY KINKED. 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 11730429 ↗MalfunctionMar 9, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11441588 ↗MalfunctionFeb 24, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. 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 11371713 ↗MalfunctionNov 18, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER NOMINAL PRESSURE AND LEAKAGE OF CONTRAST MEDIUM WAS NOTED. IT WAS FURTHER REPORTED THAT ANOTHER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10858535 ↗MalfunctionOct 27, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL U4150230RX ULTRAVERSE RX PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE AND MATERIAL DEFORMATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. PATIENTS' AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10744139 ↗MalfunctionOct 26, 2020Material Rupture; Material Rupture
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THE MODEL U4150230RX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE REPORT WAS RECEIVED FROM VARIOUS SOURCE. BOTH MALFUNCTIONS WERE INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. OF THE TWO REPORTED MALFUNCTIONS, ONE FEMALE PATIENT IS (B)(6) YEARS OLD AND WEIGHS (B)(6) KGS. THE REMAINING PATIENT'S AGE, GENDER AND WEIGHT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10738185 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 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