Ultraverse® 014 U41502H22Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741053658), received between Mar 22, 2017 and Jun 28, 2024 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionOct 20, 2022Break; Difficult to Open or Remove Packaging Material; Material Deformation; Break; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO OPEN FROM THE PACKAGE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY DEFORMED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15637510 ↗
• MalfunctionJan 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY SEPARATED FROM SHAFT AFTER BALLOONING . THE PROCEDURE WAS COMPLETED USING A COMPETITIVE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13275274 ↗
• MalfunctionJan 17, 2022Flaked; Detachment of Device or Device Component; Flaked; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY FOUND TO BE SHREDDING AND FLAKING UPON PULLING THE DEVICE OUT OF THE HOOP. THE PROCEDURE WAS COMPLETED USING A COMPETITIVE BALLOON. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13264653 ↗
• MalfunctionNov 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE USING FEMORAL ANTEGRADE APPROACH, THE PTA BALLOON ALLEGEDLY LEAKED WHILE INJECTING THE CONTRAST. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12893328 ↗
• MalfunctionOct 22, 2021Leak/Splash; Detachment of Device or Device Component; Device Dislodged or Dislocated; Leak/Splash; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD A LEAK. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12679201 ↗
• MalfunctionOct 20, 2021Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD A RUPTURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662793 ↗
• MalfunctionAug 27, 2021Difficult to Remove; Material Separation; Device-Device Incompatibility; Difficult to Remove; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY GOT STUCK ON THE GUIDEWIRE AND DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12376592 ↗
• InjuryJun 8, 2021Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ANGIOPLASTY THE PTA BALLOON ALLEGEDLY RUPTURED. REPORTEDLY, THE HEALTH CARE PROVIDER ALLEGEDLY EXPERIENCED DIFFICULTY REMOVING THE BALLOON AND THE CATHETER BROKE. IT WAS FURTHER REPORTED THAT A FRAGMENT OF THE CATHETER WAS REMOVED USING A SNARE AND THE REMAINING FRAGMENTS REMAINED IN THE PATIENT. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11954230 ↗
• MalfunctionMar 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PTA BALLOON ALLEGEDLY BALLOON BUSTED WHILE INFLATING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559125 ↗
• MalfunctionDec 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY CAME OFF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10982693 ↗
• MalfunctionApr 20, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H22 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE FOUR MALFUNCTIONS INVOLVED TWO PATIENTS WITH NO PATIENT CONSEQUENCES. ONE PATIENT WAS REPORTEDLY A 60 YEAR OLD MALE OF UNKNOWN WEIGHT. THE AGE, WEIGHT, AND GENDER OF THE OTHER PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979835 ↗
• MalfunctionApr 17, 2020Break; Packaging Problem; Break; Packaging Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H22 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK AND PACKAGING PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENT IS (B)(6) OLD, AND FEMALE; HOWEVER, THE WEIGHT WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9975238 ↗
• MalfunctionApr 18, 2019Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL U41502H22 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED THE OUTER LAYER OF THE BALLOON PEELING AFTER REMOVING THE BALLOON FROM A HEP-SALINE BOWL. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON.THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WHOSE AGE, WEIGHT AND GENDER WERE NOT PROVIDED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8528125 ↗
• MalfunctionFeb 7, 2019Break; Material Rupture; Detachment of Device or Device Component; Break; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318160 ↗
• MalfunctionJan 4, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT UPON REMOVAL FROM THE PACKAGING, FRAYED MATERIAL WAS ALLEGEDLY OBSERVED ON THE PTA BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8220213 ↗
• MalfunctionDec 22, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER WHILE REMOVING THE BALLOON GUARD. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7141436 ↗
• MalfunctionSep 18, 2017Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, IN PREPARATION FOR THE ANGIOPLASTY PROCEDURE, THE BALLOON STYLET ALLEGEDLY COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT ANOTHER PTA CATHETER WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6874596 ↗
• MalfunctionJun 28, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY DETACHED AT THE GLUE JOINT OF THE CATHETER AFTER IT WAS PULLED FROM THE PACKAGING LOOP. REPORTEDLY, THE BALLOON REMAINS INSIDE THE BALLOON GUARD. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6676001 ↗
• MalfunctionMay 25, 2017Break; Detachment of Device or Device Component; Device Operates Differently Than Expected; Break; Detachment of Device or Device Component; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DEVICE ALLEGEDLY DID NOT LOOK RIGHT AFTER OPENING THE INNER PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6592962 ↗
• MalfunctionMar 22, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON OPENING THE INNER PACKAGING THE BALLOON ALLEGEDLY WAS NOT ATTACHED TO THE BALLOON CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6425616 ↗