AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating 2200-3510-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813132026929), received between Nov 15, 2021 and Jul 8, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2025Material Separation; Material Separation

  AN ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL LAD. DURING USE, RESISTANCE WAS ENCOUNTERED AND THE DISTAL PORTION GOT DISLODGED FROM THE SHAFT. A BALLOON AND GUIDELINE WERE USED TO RETRIEVE THE SEPARATED PORTION. IMAGING CONFIRMED THAT NO DEVICE FRAGMENTS WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NC BALLOON WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM AND ADVERSE EVENT IS BEING SUBMITTED DUE TO SHAFT SEPARATION, REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441481 ↗
• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE DISTAL LAD. DURING THE FIRST INFLATION AT 6 ATM FOR 5 SECONDS, 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 17082970 ↗
• MalfunctionAug 12, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID LAD. DURING THE SIXTH INFLATION AT 15 ATM, THE BALLOON RUPTURED (PINHOLE). 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 15222096 ↗
• MalfunctionMay 31, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A MODERATELY TORTUOUS MID LAD. DURING THE 4TH INFLATION AT 15 ATM, THE BALLOON RUPTURED (PINHOLE). 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 14551497 ↗
• InjuryNov 23, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RCA. DURING ADVANCEMENT, RESISTANCE WAS NOTED LIKELY DUE TO THE VESSEL TORTUOSITY. THE BALLOON WAS INFLATED AND DEFLATED 3 TIMES UNDER RBP WITH NO ISSUES. UPON REMOVAL, RESISTANCE WAS ENCOUNTERED AND FLUOROSCOPY CONFIRMED A SHAFT SEPARATION AT THE EXIT PORT WITHIN THE GUIDE CATHETER. THE SEPARATED PORTION WAS REMOVED BY INFLATING A BALLOON WHICH REMAINED INFLATED TO PULL THE SEPARATED SECTION. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT ANGIOSCULPT DEVICE WITH NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE SEPARATED PORTION OF THE DEVICE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863296 ↗
• InjuryNov 15, 2021Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL RCA WITH 90% ISR AND SUSPECTED BLOOD CLOT. A SION BLUE GUIDEWIRE WAS INSERTED AND AN ALTAVIEW IVUS CATHETER WAS LOADED ONTO THE GUIDEWIRE AND REMOVED WITH NO ISSUES. THEN, A FILTRAP GUIDEWIDE WAS INSERTED AND THE SION BLUE GUIDEWIRE WAS REMOVED. THE ANGIOSCULPT DEVICE WAS LOADED ONTO THE FILTRAP GUIDEWIRE AND WAS INFLATED 5 TIMES TO 16 ATM. UPON REMOVAL, STRONG RESISTANCE WAS ENCOUNTERED, THUS THE FILTRAP AND ANGIOSCULPT WERE REMOVED TOGETHER AS A UNIT. REWIRING OF THE VESSEL WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DCB. 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 12817355 ↗

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.