AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating 2200-3506-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132026912), received between Aug 2, 2021 and Mar 21, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID LAD ARTERY. DURING INFLATION, IT WAS ASSUMED THAT A PINHOLE PERFORATION OCCURRED AND COVERED WITH A STENT. REGARDLESS OF THE PERFORATION, A STENT WAS PLANNED AS PART OF THE PROCEDURE. THE PATIENT WAS DOING GREAT WITH NO ISSUES. THERE WAS NO ALLEGED MALFUNCTION WITH THE ANGIOSCULPT DEVICE. THIS ADVERSE EVENT IS BEING SUBMITTED DUE TO THE PERFORATION, REQUIRING STENT PLACEMENT.

  Patient problems: Perforation

  MAUDE report 18954162 ↗
• InjuryAug 2, 2021Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LAD. DURING INFLATION, THE BALLOON WAS INFLATED TO RBP (16 ATM) AND BECAME STUCK TO THE GUIDEWIRE. THE ANGIOSCULPT DEVICE AND THE GUIDEWIRE WERE REMOVED TOGETHER AND LOST WIRE ACCESS. REWIRING OF THE VESSEL WAS PERFORMED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE ANGIOSCULPT DEVICE AND THE NON-MANUFACTURER'S GUIDEWIRE WERE REMOVED AS A UNIT, RESULTING IN ADDITIONAL INTERVENTION TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264445 ↗

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.