AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating 2200-3010-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00813132026882), received between Oct 26, 2021 and May 1, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC CORONARY PROCEDURE. DURING INFLATION AT 14 ATM (RBP: 16 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 25059962 ↗
• InjuryMar 6, 2025Entrapment of Device; Entrapment of Device

  AN ANGIOSCULPT DEVICE WAS USED IN A CORONARY ISR PROCEDURE. DURING USE, THE BALLOON GOT STUCK INSIDE THE EXISTING STENT. FOR REMOVAL, THE HUB WAS CUT OFF, AND THEN AN ADDITIONAL GUIDEWIRE AND NC BALLOON WERE PLACED/INFLATED ADJACENT TO WHERE THE BALLOON WAS STUCK. THE ANGIOSCULPT DEVICE WAS ABLE TO BE REMOVED AND UPON REMOVAL, IT WAS NOTED THAT THE SCORING ELEMENT WAS BENT. IMAGING CONFIRMED THAT NO DEVICE FRAGMENTS WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM AND ADVERSE EVENT IS BEING SUBMITTED DUE TO DEVICE ENTRAPMENT, REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536869 ↗
• InjuryNov 19, 2024Use of Device Problem; Use of Device Problem

  THE ANGIOSCULPT CATHETER WAS USED IN A CORONARY PROCEDURE. DURING PREP, THE STYLET WAS DIFFICULT TO REMOVE, THUS THE PHYSICIAN PULLED HARD ON THE SHAFT TO REMOVE. PRIOR TO USE, THE CATHETER WAS ASPIRATED, BUT NOT FLUSHED. DURING INFLATION AT 8 ATM, THE BALLOON RUPTURED, AND A SMALL AIR EMBOLISM TRAVELED INTO THE DISTAL CORONARY BED CAUSING THE PATIENT TO EXPERIENCE TEMPORARY ANGINA. THE ANGINA WAS RESOLVED WITH NO ADDITIONAL INTERVENTION REQUIRED. A NEW ANGIOSCULPT WAS USED TO COMPLETE THE PROCEDURE AND PATIENT LEFT THE ROOM WITHOUT PAIN. DURING THE DEVICE EVALUATION, THERE WAS NO BALLOON RUPTURE PRESENT. THIS ADVERSE EVENT IS BEING SUBMITTED DUE TO USER ERROR; RESULTING IN EMBOLISM.

  Patient problems: Air Embolism; Angina

  MAUDE report 20729129 ↗
• MalfunctionDec 4, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID RCA. DURING THE FIRST INFLATION AT NOMINAL (8 ATM) PRESSURE, 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 18261821 ↗
• MalfunctionDec 15, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A CALCIFIED DISTAL LAD LESION. DURING THE FIRST INFLATION AT 6 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 15992581 ↗
• MalfunctionNov 2, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID LAD LESION. DURING INFLATION BEFORE 6 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 15715333 ↗
• InjuryJul 20, 2022Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT DEVICE WAS USED IN THE RCA. THE BALLOON WAS INFLATED UP TO 16 ATM AND DEFLATED WITH NO ISSUES. UPON REMOVAL, THE DEVICE GOT STUCK ON THE NON-MANUFACTURER'S GUIDEWIRE, THUS WERE REMOVED AS A UNIT. THE LESION WAS RE-WIRED AND 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 GUIDEWIRE AND WERE REMOVED AS A UNIT. PLACEMENT OF A NEW GUIDEWIRE WAS NECESSARY TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15068374 ↗
• InjuryOct 26, 2021Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL RCA. DURING INFLATION AT ABOVE RBP (18 ATM), THE BALLOON RUPTURED. UPON REMOVAL, RESISTANCE WAS ENCOUNTERED AND THE ANGIOSCULPT AND GUIDEWIRE WERE REMOVED AS A UNIT. A NEW GUIDEWIRE AND NON-ANGIOSCULPT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE RETURNED PRODUCT ANALYSIS, THE BALLOON RUPTURE COULD NOT BE CONFIRMED THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ANGIOSCULPT AND GUIDEWIRE WERE 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 12700974 ↗

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.