ULTRASCORE US35130630Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741116926), received between Jul 12, 2018 and Dec 20, 2019 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 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 RIGHT FEMORAL ARTERY, TYPE A DISSECTION WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT INTERVENTION WAS PERFORMED. PATIENT WAS DISCHARGED THE SAME DAY AS THE PROCEDURE. APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE, DUPLEX ULTRASOUND DEMONSTRATED TARGET LESION OCCLUSION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Occlusion; Vascular Dissection

  MAUDE report 9500431 ↗
• InjuryNov 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 IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, THE PATIENT HAD ELASTIC RECOIL OF THE DISTAL SFA. A PTA BALLOON AND DRUG-COATED BALLOON WERE USED FOR RESIDUAL STENOSIS AND TO TREAT THE ELASTIC RECOIL. THERE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Injury

  MAUDE report 9276180 ↗
• 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, THAT AFTER AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER, NON-FLOW LIMITING DISSECTION OF TARGET LESION WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT SURGICAL INTERVENTION WAS PERFORMED.

  Patient problems: Vascular Dissection

  MAUDE report 9261674 ↗
• InjurySep 19, 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 APPROXIMATELY 6-MONTH POST INDEX PROCEDURE, STENOSIS WAS IDENTIFIED VIA DUPLEX ULTRASOUND. IT WAS FURTHER REPORTED THAT INTERVENTION WAS PERFORMED WITH SUCCESSFUL RESULT.

  Patient problems: Stenosis

  MAUDE report 9088584 ↗
• InjuryMay 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 APPROXIMATELY 21 DAYS POST INDEX PROCEDURE, AN ABOVE KNEE AMPUTATION WAS PERFORMED DUE TO NON-HEALING LEFT METATARSAL AMPUTATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8642658 ↗
• InjuryJan 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 AFTER AN ANGIOPLASTY PROCEDURE WITH A FOCUSED FORCE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON DILATATION CATHETER, DISSECTION WAS IDENTIFIED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 8210958 ↗
• InjuryDec 21, 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 ONE INFLATION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A BARE METAL 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: Vascular Dissection

  MAUDE report 8189580 ↗
• InjuryJul 12, 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 BALLOON DILATATION CATHETER, A FLOW LIMITING DISSECTION WAS IDENTIFIED AFTER TWO INFLATIONS IN THE SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, THE DISSECTION WAS TREATED WITH A STENT; FINAL ANGIOGRAM DEMONSTRATED EXCELLENT RESULT.

  Patient problems: Vascular Dissection

  MAUDE report 7684232 ↗