AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating 2237-60100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813132022846), received between Sep 2, 2020 and Sep 16, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791906 ↗
• InjuryMay 1, 2025Material Separation; Material Separation

  AN ANGIOSCULPT CATHETER WAS USED IN A PERIPHERAL PROCEDURE TO TREAT A SEVERELY CALCIFIED MID SFA. THE ANGIOSCULPT WAS ADVANCED TO THE LESION AND INFLATED WITH NO ISSUES. HOWEVER, DURING REMOVAL, RESISTANCE WAS NOTED, AND THE SCORING ELEMENT GOT STUCK IN THE CALCIUM. SOME DEGREE OF FORCE WAS APPLIED, BUT THE SCORING ELEMENT SEPARATED IN THE PATIENT. ATTEMPTS TO RETRIEVE THE SCORING ELEMENT WAS NOT SUCCESSFUL; THEREFORE, A STENT WAS PLACED TO TRAP TO THE VESSEL WALL. THIS PRODUCT PROBLEM AND ADVERSE EVENT IS BEING SUBMITTED DUE TO SCORING ELEMENT SEPARATION, REQUIRING INTERVENTION, BUT RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21946364 ↗
• MalfunctionApr 11, 2024Sharp Edges; Sharp Edges

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID SFA. DURING ADVANCEMENT, RESISTANCE WAS NOTED, BUT THE BALLOON WAS INFLATED WITH NO ISSUES. DURING REMOVAL, RESISTANCE WAS NOTED AGAIN, BUT THIS TIME THE DEVICE GOT STUCK IN THE ANATOMY. MILD DEGREE OF FORCE WAS APPLIED AND WAS ABLE TO BE REMOVED AS A SYSTEM. UPON REMOVAL, THE SCORING ELEMENT DETACHED FROM THE BALLOON; HOWEVER, IT WAS CONFIRMED THAT NO DEVICE FRAGMENT WAS RETAINED INSIDE THE PATIENT. A STANDARD BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS STABLE AND RECOVERING WELL, WITH NO INJURY REPORTED. PHOTO OBTAINED SHOWS A SEGMENT OF THE SCORING ELEMENT DETACHED, EXPOSING A SHARP EDGE. THIS PRODUCT PROBLEM IS BEING REPORTED DUE THE SHARP EDGE OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088768 ↗
• InjuryFeb 16, 2023Material Separation; Material Separation

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE LEFT SFA. UPON REMOVAL, THE CATHETER SEPARATED IN THE PATIENT. A SNARE WAS USED, BUT ONLY A PORTION OF THE DEVICE WAS RETRIEVED. THE OTHER PORTION WAS RETAINED IN THE PATIENT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SHAFT SEPARATION REQUIRING MEDICAL INTERVENTION, BUT PARTIAL DEVICE WAS RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16390413 ↗
• MalfunctionNov 10, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED DISTAL SFA. DURING INFLATION AT 4 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789136 ↗
• InjurySep 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO DIFFICULTIES WITH ADVANCEMENT. THE BALLOON WAS INFLATED TO 10 ATM, 3-4 TIMES WITH NO ISSUES. DESPITE A LONG DEFLATION TIME, THERE WAS DIFFICULTY INSERTING THE BALLOON INTO THE INTRODUCER SHEATH, IMPOSING A BACK AND FORTH MANEUVER WITH THE DEFLATED BALLOON. AFTER MANY TRIES, A DECISION WAS MADE TO EXTRACT THE INTRODUCER SHEATH WITH THE BALLOON PARTIALLY INSERTED. DURING THIS TIME, RESISTANCE WAS NOTED IN THE CONTRALATERAL AXE DUE TO THE STENTS LIKELY BLOCKING THE SCORING ELEMENT FROM REMOVAL. THE INTRODUCER SHEATH AND DEVICE WERE EXTRACTED AS A UNIT, BUT ONE OF THE SCORING ELEMENT WAS ABSENT. UNDER FLUOROSCOPY, VISUALIZATION OF THE SCORING ELEMENT WAS OBSERVED IN THE ARTERIAL AXE. IMMEDIATE SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE DETACHED SCORING ELEMENT. PATIENT STATUS TODAY REMAINS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10486026 ↗