AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating 2216-30100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813132022914), received between Sep 11, 2018 and Sep 12, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Deflation Problem; Deflation Problem

  THE ANGIOSCULPT DEVICE WAS USED IN A PERIPHERAL PROCEDURE OF A SLIGHTLY FIBROUS DISTAL SFA. AFTER INFLATION AT 12 ATM, THE BALLOON WAS UNABLE TO DEFLATE AND GOT STUCK BUT REMOVED SUCCESSFULLY WITHOUT ADDITIONAL INTERVENTION. UPON REMOVAL, IT WAS OBSERVED THAT THE SCORING ELEMENT DETACHED FROM THE BALLOON BUT REMAINED INTACT TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE BALLOON UNABLE TO DEFLATE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040919 ↗
• InjurySep 16, 2024Deflation Problem; Deflation Problem

  THE ANGIOSCULPT CATHETER WAS USED TO TREAT A SLIGHTLY CALCIFIED DISTAL ANTERIOR TIBIAL ARTERY. THE BALLOON WAS INFLATED TO 8 ATM WITH NO ISSUES; HOWEVER, THE BALLOON WAS UNABLE TO DEFLATE. AN ACCESS NEEDLE WAS USED TO PUNCTURE THE BALLOON THROUGH THE SKIN AT THE AT/PEDAL AREA. THE PROCEDURE WAS COMPLETED WITH A 2.0 NON-PHILIPS DILATATION BALLOON TO TAMPONADE THE PUNCTURED AREA. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM AND ADVERSE EVENT IS BEING SUBMITTED DUE TO THE ANGIOSCULPT BALLOON UNABLE TO DEFLATE, REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226305 ↗
• InjuryAug 30, 2023Deflation Problem; Material Separation; Deflation Problem; Material Separation

  THE ANGIOSCULPT CATHETER WAS USED TO TREAT A MODERATELY CALCIFIED PROXIMAL PT LESION. THE BALLOON WAS INFLATED WITH NO ISSUES. AFTER INFLATION, THE BALLOON WOULD NOT FULLY DEFLATE AFTER 5 MINUTES OF APPLYING NEGATIVE PRESSURE. THE BALLOON SEIZED ON THE GUIDE WIRE AND HAD TO BE WITHDRAWN AS A UNIT. UPON ENTERING THE SHEATH, RESISTANCE WAS NOTED, THUS SIGNIFICANT FORCE WAS APPLIED TO WITHDRAW THE CATHETER FROM THE GUIDE WIRE. THE CATHETER WAS ABLE TO BE REMOVED, BUT THE DISTAL PORTION OF THE BALLOON SEPARATED INSIDE THE SHEATH. AN ADDITIONAL GUIDE WIRE WAS ATTEMPTED TO ASSIST WITH REMOVAL OF THE SEPARATED PORTION, BUT WAS NOT POSSIBLE. THE SHEATH WAS REMOVED WITH THE DISTAL PORTION OF THE CATHETER WITHIN THE SHEATH. NO PATIENT INJURY REPORTED THIS IS BEING REPORTED DUE TO THE BALLOON UNABLE TO DEFLATE AND SHAFT SEPARATION REQUIRING ADDITIONAL INTERVENTION TO ASSIST WITH REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650601 ↗
• MalfunctionMay 17, 2023Deflation Problem; Material Separation; Deflation Problem; Material Separation

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE DISTAL ANTERIOR TIBIAL (AT) ARTERY. THE BALLOON WAS INFLATED WITH NO ISSUES. DURING REMOVAL, THE BALLOON WAS UNABLE TO DEFLATE AND THE DEVICE BARELY MANAGED TO PRY OUT OF THE AT. THEREFORE, THE BALLOON AND THE INTRODUCER GUIDE WERE REMOVED AS A SYSTEM, BUT THE BALLOON SEPARATED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE TO THE BALLOON UNABLE TO DEFLATE AND THE SHAFT SEPARATION. THERE IS A POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945953 ↗
• InjurySep 11, 2018Deflation Problem; Deflation Problem

  THE ANGIOSCULPT DEVICE WAS INFLATED BELOW RBP WITH NO ISSUES. DURING REMOVAL, THE BALLOON WAS UNABLE TO DEFLATE. THE PHYSICIAN INFLATED THE BALLOON AND DEFLATED MULTIPLE TIMES AND EVENTUALLY THE BALLOON WAS ABLE TO DEFLATE APPROXIMATELY 10 MINUTES LATER. THE BALLOON, GUIDEWIRE, AND SHEATH WERE REMOVED AS A UNIT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7863870 ↗