ULTRASCORE US3513058Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741116766), received between Dec 28, 2018 and Dec 3, 2024 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Material Puncture/Hole; Material Rupture; Material Deformation; Material Puncture/Hole; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM AND THE CONTRAST ESCAPED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20829287 ↗
• MalfunctionOct 18, 2024Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FORCEFULLY GUIDED THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE TIP OF THE CATHETER GOT STUCK IN THE TIP OF THE SHEATH WHEN REMOVING AND PULLING BACK OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478990 ↗
• MalfunctionJun 27, 2024Break; Difficult to Insert; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn; Break; Difficult to Insert; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE SHEATH. IT WAS FURTHER REPORTED THAT A LOT OF FORCE WAS NEEDED TO PULL IT OUT THROUGH THE SHEATH. REPORTEDLY, THE BALLOON ALLEGEDLY TORE AT THE DISTAL END OF THE BALLOON. FURTHERMORE, THE BALLOON WAS NOTED TO BE RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621894 ↗
• MalfunctionMar 19, 2024Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD A LEAK AND COULD NOT INFLATED. IT WAS FURTHER REPORTED THE DEVICE ALLEGEDLY HAD A DETACHMENT ISSUE. REPORTEDLY THE BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT WITHOUT USE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928649 ↗
• MalfunctionDec 7, 2023Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY GOT STUCK WITHIN THE SHEATH UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283223 ↗
• MalfunctionNov 7, 2022Break; Leak/Splash; Device Dislodged or Dislocated; Break; Leak/Splash; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742414 ↗
• MalfunctionMar 30, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY COULD NOT BE RETRIEVED THROUGH SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY STUCK IN SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13951268 ↗
• MalfunctionMar 7, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT POST ANGIOPLASTY PLACEMENT PROCEDURE IN THE SFA /POP THROUGH FEMORAL, THE DEVICE ALLEGEDLY COULD NOT BE REMOVED FROM THE SHEATH / SCORINGWIRES. IT WAS FURTHER REPORTED THAT THE SCORINGWIRE FOUND TO BE WORN OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13683956 ↗
• MalfunctionJan 22, 2021Difficult to Insert; Peeled/Delaminated; Difficult to Insert; Peeled/Delaminated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL US3513058 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DIFFICULT TO INSERT AND PEELED OR DELAMINATED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. PATIENTS' AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11218984 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER IN THE MID AND DISTAL 1/3 OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, VESSEL DISSECTION AND AV FISTULA WERE IDENTIFIED. IT WAS FURTHER REPORTED THAT A DRUG COATED BALLOON AND A STENT GRAFT WERE USED TO TREAT THE PATIENT. APPROXIMATELY 3-MONTH POST INDEX PROCEDURE, PATIENT EXPIRED.

  Patient problems: Death; Vascular Dissection

  MAUDE report 8740046 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, VESSEL DISSECTION WAS IDENTIFIED AFTER INFLATION IN THE SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A NON DRUG COATED PTA BALLOON DILATATION CATHETER AND THE EVENT WAS CONSIDERED TO BE RESOLVED.

  Patient problems: Vascular Dissection

  MAUDE report 8728501 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, VESSEL DISSECTION WAS IDENTIFIED IN THE SUPERFICIAL FEMORAL ARTERY. IT WAS FURTHER REPORTED A BARE METAL STENT WAS PLACED AT THE TARGETED LESION. PATIENT WAS DISCHARGED SAME DAY FROM HOSPITAL.

  Patient problems: Vascular Dissection

  MAUDE report 8583067 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT FOLLOWING AN ANGIOPLASTY PROCEDURE IN THE PROXIMAL 1/3 OF THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, NON-FLOW LIMITING DISSECTION WAS IDENTIFIED WHICH REQUIRED USE OF ADDITIONAL PTA BALLOON, DRUG COATED PTA BALLOON, AND PLACEMENT OF STENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NEW INFORMATION: IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL STUDY TRIAL, APPROXIMATELY 12-MONTH POST INDEX PROCEDURE, OCCLUSION WAS IDENTIFIED VIA DUPLEX ULTRASOUND. NO TREATMENT HAS BEEN PROVIDED AT THIS MOMENT.

  Patient problems: Occlusion; Vascular Dissection

  MAUDE report 8237707 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, VESSEL DISSECTION WAS IDENTIFIED AFTER TWO INFLATIONS IN THE LEFT SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A STENT. THE EVENT WAS CONSIDERED TO BE RESOLVED. THE PATIENT WAS DISCHARGED THE SAME DAY AS THE INDEX PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 8203571 ↗