Ultraverse® RX U41501Q1HRXRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741055546), received between May 9, 2017 and Jul 14, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING ULTRAVERSE RX BALLOON. DURING THE PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491624 ↗
• MalfunctionJul 2, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE RX. DURING THE 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 22382652 ↗
• MalfunctionMay 26, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, PRIOR TO AN ANGIOPLASTY PROCEDURE IN A BK CASE WHERE THE ANKLE JOINT OF THE PA WAS BLOCKED USING AN ULTRAVERSE RX BALLOON, AFTER PASSING THE GUIDEWIRE, THE PRODUCT WAS ATTEMPTED TO EXPAND DURING THE FIRST EXPANSION, BUT IT RUPTURED BEFORE IT COULD BE PRESSURIZED TO 6 ATM. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083141 ↗
• MalfunctionFeb 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD NO PRESSURE WHEN DILATED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED FROM THE BODY AND A BALLOON RUPTURE WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408493 ↗
• MalfunctionJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SEVERELY STENOTIC SUPERFICIAL FEMORAL ARTERY LESION, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19603941 ↗
• MalfunctionMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372212 ↗
• MalfunctionMar 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE HIGHLY CALCIFIED BELOW KNEE TREATMENT VIA AN IPSILATERAL ANTEGRADE APPROACH, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859587 ↗
• MalfunctionOct 26, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41501Q1HRX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE DEVICE WAS USED IN A FEMALE PATIENT. AGE AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738166 ↗
• MalfunctionJul 22, 2020Material Rupture; Material Separation; Detachment of Device or Device Component; Material Rupture; Material Separation; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41501Q1HRX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL SEPARATION AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE SEX AND WEIGHT OF THE 83 YEAR OLD PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310322 ↗
• MalfunctionJul 22, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41501Q1HRX PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310295 ↗
• MalfunctionJul 22, 2020Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41501Q1HRX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE AND BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE FEMALE PATIENT'S AGE AND WEIGHT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310252 ↗
• MalfunctionJul 22, 2020Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41501Q1HRX PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6)KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306515 ↗
• MalfunctionApr 17, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL U41501Q1HRX, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES. TWO PATIENTS WERE INVOLVED WITH NO CONSEQUENCES. NEITHER PATIENTS AGE, WEIGHT, OR GENDER WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9975393 ↗
• MalfunctionApr 17, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL U41501Q1HRX ULTRAVERSE RX PTA DILATATION CATHETER RUPTURED. OF THIS EVENT, THE DEVICE WAS USED ON THE PATIENT BUT THE PATIENT WAS NOT INJURED. THE FEMALE PATIENT¿S AGE AND WEIGHT WERE NOT PROVIDED. THE U41501Q1HRX ULTRAVERSE RX PTA DILATATION CATHETER WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525304 ↗
• MalfunctionMay 9, 2017Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT DURING THE TREATMENT FOR CHRONIC TOTAL OCCLUSION (CTO) WITH CALCIFICATION IN THE LEFT ANTERIOR TIBIAL ARTERY (ATA) BY AN IPSILATERAL ANTEGRADE APPROACH, APPROXIMATELY 20 CM OF RIBBON-LIKE MATERIAL OF THE PTA CATHETER WAS ALLEGEDLY FOUND WHEN IT WAS REMOVED FROM THE PATIENT. BEFORE THE CATHETER REMOVAL, THE HEALTH CARE PROVIDER ATTEMPTED TO PASS THE CATHETER THROUGH THE LESION BUT FAILED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6556169 ↗