ULTRASCORE US3513054Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741116742), received between Mar 1, 2019 and May 21, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ULTRASCORE 035 PTA BALLOON CATHETER. DURING THE PROCEDURE, THE CATHETER ALLEGEDLY GOT STUCK AT THE TIP OF THE SHEATH AND THE CATHETER HAD TO BE REMOVED TOGETHER WITH THE SHEATH. IT WAS FURTHER REPORTED THAT AFTER REMOVAL, THE BALLOON SECTION WAS KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058330 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT APPROXIMATELY SEVEN MONTHS AND THIRTEEN DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT TARGET LIMB RE-INTERVENTION ON THE LEFT SUPERFICIAL FEMORAL ARTERY BY USING SCORING BALLOON AND DRUG COATED BALLOON. IT WAS FURTHER REPORTED THAT DURING RE-INTERVENTION, THE SUBJECT HAD AN ADVERSE EVENT OF DISSECTION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY ON THE LEFT LEG . REPORTEDLY, THE ADVERSE EVENT WAS NOT RELATED TO STUDY DEVICE AND STUDY PROCEDURE AND THE LESION WAS STENTED. FURTHERMORE, THE SUBJECT HAD AN ANOTHER ADVERSE EVENT OF CIRCULATORY DYSREGULATION OF HYPOTENSION AND BRADYCARDIA AFTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 21571090 ↗
• MalfunctionMay 25, 2024Leak/Splash; Device Dislodged or Dislocated; Leak/Splash; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA CROSS OVER APPROACH, THE PTA BALLOON ALLEGEDLY LEAKED AT THE HUB AT 12 ATM DURING THE FIRST DILATION. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398133 ↗
• MalfunctionMay 2, 2024Leak/Splash; Device Dislodged or Dislocated; Leak/Splash; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY LEAKED AT THE BASE OF THE Y-PIECE, SO THAT THE CONTRAST MEDIUM FOR INFLATING THE BALLOON DRIPPED NEXT TO IT AND COULD NOT BUILD UP ANY PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227732 ↗
• MalfunctionJan 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY TORN AT THE SUPPLY LINE AND THERE WAS A LEAKAGE AT SHAFT. IT WAS FURTHER REPORTED THAT IT ALLEGEDLY TEARED DURING DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472933 ↗
• MalfunctionJan 10, 2023Break; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Break; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RIPPED OFF. IT WAS FURTHER REPORTED THAT CATHETER WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129087 ↗
• MalfunctionMar 7, 2022Break; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Break; Difficult to Remove; Device-Device Incompatibility; 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 13683938 ↗
• MalfunctionJan 12, 2022Crack; Leak/Splash; Detachment of Device or Device Component; Device Dislodged or Dislocated; Crack; Leak/Splash; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA TRANSBRONCHIAL ACCESS, THE LEAK WAS ALLEGEDLY FOUND IN THE SHAFT AREA. IT WAS FURTHER REPORTED THAT GREY PART WAS ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235421 ↗
• InjuryMay 2, 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 THREE BARE METAL STENTS WERE PLACED AT THE TARGETED LESION. PATIENT WAS DISCHARGED SAME DAY FROM HOSPITAL.

  Patient problems: Vascular Dissection

  MAUDE report 8575935 ↗
• InjuryMay 1, 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 8569073 ↗
• InjuryMar 4, 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 ONE DAY POST INDEX PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 8387425 ↗
• InjuryMar 1, 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 ONE DAY POST INDEX PROCEDURE. NEW INFORMATION: IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE, TARGET LESION STENOSIS WAS ALLEGEDLY IDENTIFIED VIA IMAGING. IT WAS FURTHER REPORTED THAT RE-INTERVENTION WAS PERFORMED WITH SUCCESSFUL RESULT.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 8384086 ↗