ULTRASCORE US35130515Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741116797), received between Jul 12, 2018 and Sep 24, 2024 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionSep 24, 2024Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED DURING INFLATION. IT WAS FURTHER REPORTED THAT THE PTA BALLOON ALLEGEDLY HAD RUPTURE DUE TO THE CONNECTION BETWEEN THE CATHETER AND PLASTIC PIECE THAT CONNECTS TO THE BALLOON AND WIRE PORT. REPORTEDLY, THE PTA BALLOON WAS PULLED OUT OF THE BODY AND OFF THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294396 ↗
• MalfunctionMay 27, 2021Break; Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn; Break; Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA CATHETER SHAFT OF THE DEVICE WAS ALLEGEDLY DEFORMED. IT WAS FURTHER REPORTED THAT SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894218 ↗
• MalfunctionNov 12, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH SFA, THE CATHETER SHAFT ALLEGEDLY BUSTED. 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 10828066 ↗
• MalfunctionJul 18, 2020Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL US35130515 PTA BALLOON DILATATION CATHETER ALLEGEDLY HAD A RETRACTION ISSUE AND BREAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6). WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10293433 ↗
• InjuryOct 31, 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 DURING ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, DISSECTION TYPE B WAS IDENTIFIED AND A STENT WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Vascular Dissection

  MAUDE report 9261685 ↗
• InjuryOct 31, 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 DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, TYPE B DISSECTION WAS IDENTIFIED AND A STENT WAS PLACED. APPROXIMATELY 6.5 MONTHS POST INDEX PROCEDURE, THE TARGET LESION WAS EXPERIENCING 50-99% STENOSIS. APPROXIMATELY SEVEN MONTHS POST INDEX PROCEDURE, THE TARGET LESION AND TARGET VESSEL WERE SUCCESSFULLY TREATED WITH STANDARD PTA. THE SUBJECT COMPLETED THE STUDY.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 9261676 ↗
• InjuryOct 15, 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 11-MONTH POST INDEX PROCEDURE, ANGIOGRAPHY WAS PERFORMED(B)(6)2019 . IT WAS IDENTIFIED THAT TARGET LESION WAS 100% OCCLUDED. ATHERECTOMY, THROMBOLYSIS, AND DRUG- ELUTING STENT WERE PERFORMED AND PLACED WITH SUCCESSFUL RESULT.

  Patient problems: Stenosis

  MAUDE report 9194959 ↗
• InjurySep 11, 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 6-MONTH FOLLOW-UP VISIT, DUPLEX ULTRASOUND WAS PERFORMED AND 50-90% STENOSIS WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT TARGET LESION REVASCULARIZATION WAS PERFORMED ON (B)(6) 2019.

  Patient problems: Stenosis

  MAUDE report 8997647 ↗
• InjuryJul 30, 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 APPROXIMATELY THREE-MONTH POST ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER IN THE LEFT SUPERFICIAL FEMORAL ARTERY, ULTRASOUND DEMONSTRATED STENOSIS IN THE TARGET LESION. IT WAS FURTHER REPORTED THAT DRUG COATED BALLOON AND ATHERECTOMY WERE USED TO TREAT THE LESION RESULT IN SUCCESSFUL PROCEDURE. NEW INFORMATION: APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, INTRAVASCULAR ULTRASOUND AND AN ATHERECTOMY WERE PERFORMED AS RE-INTERVENTION TO THE LEFT SUPERFICIAL ARTERY THAT HAD AN 80% CONCENTRIC CALCIFIC LESION AT THE MIDPORTION. NEW INFORMATION: APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, AN ATHERECTOMY AND PTA WERE USED AS TREATMENT IN THE TARGET LESION WHICH REDUCED STENOSIS FROM 59% TO 10%. NEW INFORMATION: IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT DURING 12-MONTH FOLLOW-UP VISIT, DUPLEX ULTRASOUND WAS PERFORMED AND 50-90% STENOSIS WAS IDENTIFIED.

  Patient problems: Calcium Deposits/Calcification; Stenosis

  MAUDE report 8841863 ↗
• InjuryFeb 25, 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 DISTAL 1/3 OF THE LEFT SUPERFICIAL FEMORAL ARTERY WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, DISSECTION WAS IDENTIFIED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 8366640 ↗
• InjuryFeb 14, 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 ONE INFLATION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THERE WAS NO REPORTED TREATMENT OF THE DISSECTION. THE CURRENT STATS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 8341429 ↗
• MalfunctionJul 12, 2018Break; Break

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT DURING AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATION CATHETER, UPON REMOVAL OF THE DEVICE, A WIRE WAS NOTED TO BE DETACHED FROM THE TIP OF THE BALLOON. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7684293 ↗