AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating 2200-3020-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813132026905), received between Nov 15, 2023 and Jun 25, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED IN A CORONARY PROCEDURE. DURING REMOVAL, THE CATHETER GOT STUCK INSIDE THE GUIDE CATHETER AND HAD TO BE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326218 ↗
• MalfunctionMay 29, 2025Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED IN A CORONARY PROCEDURE IN THE DISTAL CIRCUMFLEX ARTERY. DURING REMOVAL, DIFFICULTY WAS ENCOUNTERED WHEN REMOVING FROM THE GUIDEWIRE; THEREFORE, THE ANGIOSCULPT AND GUIDEWIRE WERE REMOVED AS A SYSTEM. UPON REMOVAL, THE SCORING ELEMENT WAS UNRAVELED, BUT REMAINED INTACT TO THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109170 ↗
• InjuryJan 14, 2025Material Separation; Material Separation

  AN ANGIOSCULPT CATHETER WAS USED TO TREAT A SEVERELY CALCIFIED PROXIMAL LAD ARTERY. DURING DELIVERY AND REMOVAL, RESISTANCE WAS ENCOUNTERED. WHILE REMOVING FROM THE PATIENT, SOME DEGREE OF FORCE WAS APPLIED, BUT THE SHAFT SEPARATED. THE SEPARATED PORTION WAS REMOVED SUCCESSFULLY WITH A SNARE. IMAGING CONFIRMED THAT NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT DEVICE WITH NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SHAFT SEPARATION REQUIRING MEDICAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152505 ↗
• MalfunctionNov 15, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS PROXIMAL RCA. DURING THE SECOND INFLATION AT 10 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 18142079 ↗

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.