AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating 2200-2020-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132026820), received between Mar 31, 2022 and Mar 31, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

3 other recalls cover devices cleared under the same FDA submission (P050018); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2022Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT DEVICE WAS USED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED RCA. AFTER INFLATION/DEFLATION AND UPON REMOVAL, THE ANGIOSCULPT GOT STUCK ON THE GUIDE WIRE, THUS WERE REMOVED AS A UNIT. OUTSIDE OF THE PATIENT, THE GUIDEWIRE WAS DISLODGED FROM THE ANGIOSCULPT AND REINSERTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE ANGIOSCULPT GOT STUCK ON A NON-MANUFACTURER'S GUIDE WIRE AND REMOVED AS A UNIT. PLACEMENT OF A NEW GUIDE WIRE WAS NECESSARY TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13970897 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P050018. One submission often covers many models, so check the product and lot details in each record.

• Z-0576-2020 · Dec 7, 2018 · Terminated
  Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics
• Z-2218-2010 · Dec 4, 2009 · Terminated
  AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter
• Z-0591-2008 · Nov 13, 2007 · Terminated
  AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.