AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating 2200-3015-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00813132026899), received between Nov 1, 2021 and Sep 24, 2026 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Entrapment of Device; Detachment of Device or Device Component

  The AngioSculpt catheter was used for a therapeutic coronary procedure in the LAD. During use, the catheter got stuck, and had to pull together with the guidewire and guide catheter. The procedure was completed with a regular balloon. No patient injury reported.During device analysis, a detached scoring element was observed.This Product Problem is being submitted due to the removal as a system and detached scoring element; potential for harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876933 ↗
• MalfunctionSep 3, 2026Entrapment of Device; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596812 ↗
• MalfunctionJun 8, 2026Detachment of Device or Device Component

  THE ANGIOSCULPT CATHETER WAS USED IN A THERAPEUTIC CORONARY PROCEDURE. DURING USE, FOLLOWING TWO INFLATIONS, THE CATHETER WAS DIFFICULT TO REMOVE FROM THE VESSEL. UPON REMOVAL, THE BALLOON AND SCORING ELEMENT HAD COME APART. THE PROCEDURE WAS COMPLETED WITH A DRUG-ELUTING STENT WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A DETACHED SCORING ELEMENT; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436486 ↗
• InjuryMay 1, 2026Detachment of Device or Device Component

  THE ANGIOSCULPT DEVICE WAS USED FOR A THERAPEUTIC CORONARY PROCEDURE IN A SEVERELY CALCIFIED PROXIMAL LAD. DURING USE, THE BALLOON WAS FOUND HANGING INSIDE THE PATIENT'S BODY, LEADING TO A DISSECTION. BASED ON THE DEVICE PHOTO RECEIVED, THE SCORING ELEMENT DETACHED FROM THE INTERMEDIATE BOND, BUT REMAINED INTACT TO THE DEVICE. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO DETACHED SCORING ELEMENT; RESULTED IN A DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 25060244 ↗
• InjuryFeb 4, 2026Entrapment of Device; Material Separation

  THE ANGIOSCULPT DEVICE WAS USED IN A THERAPEUTIC CORONARY PROCEDURE FOR A MODERATELY CALCIFIED PROXIMAL LAD. DURING USE, THE SCORING BALLOON BECAME STUCK IN THE VESSEL AND WAS UNABLE TO MOVE. SEVERAL APPROACHES WERE ATTEMPTED TO REMOVE; HOWEVER, THE CATHETER SHAFT SEPARATED. THE PROXIMAL PORTION WAS REMOVED FROM THE PATIENT, AND THE DISTAL PORTION WAS RETAINED BY INSERTING A NEW GUIDEWIRE TO PASS THROUGH THE BALLOON, AND STENTS WERE PLACED TO CRUSH TO THE VESSEL WALL. THE PATIENT IS IN STABLE CONDITION AND UNDER OBSERVATION. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO DEVICE SEPARATION, REQUIRING INTERVENTION BUT RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24260584 ↗
• MalfunctionJan 23, 2026Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A CORONARY PROCEDURE OF A SEVERELY CALCIFIED MID LAD. DURING THE SECOND 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 24169288 ↗
• MalfunctionJun 18, 2025Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED IN A CORONARY PROCEDURE OF A MODERATELY CALCIFIED LESION. DURING USE, THE ANGIOSCULPT GOT STUCK IN THE LEFT MAIN, AND COULD NOT BE RETRIEVED FROM THE DISTAL PORTION OF THE GUIDE CATHETER. THEREFORE, THE ANGIOSCULPT, GUIDE CATHETER, AND GUIDEWIRE WERE REMOVED AS A SYSTEM; LOSING GUIDEWIRE ACCESS. UPON REMOVAL, THE SCORING ELEMENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A NON-COMPLIANT BALLOON. 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 22284627 ↗
• MalfunctionAug 15, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED PROXIMAL LAD. DURING THE FIRST INFLATION AT 12 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 17548685 ↗
• MalfunctionMar 23, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY TORTUOUS AND SLIGHTLY CALCIFIED DISTAL RCA. DURING THE FIRST INFLATION BELOW 8 ATM (NOMINAL), 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 16600656 ↗
• InjuryFeb 10, 2023Material Separation; Material Separation

  THE ANGIOSCULPT CORONARY DEVICE WAS USED OFF-LABEL IN A PERIPHERAL PROCEDURE TO TREAT THE PROXIMAL RIGHT PERINEAL ARTERY. UPON REMOVAL, RESISTANCE WAS NOTED AND THE DEVICE SEPARATED AT THE INTERMEDIATE SHAFT. UNDER FLUOROSCOPY, THE SEPARATED PORTION WAS LOCATED IN THE AORTA JUST BEFORE THE FEMORAL BIFURCATION. AN ATTEMPT TO SNARE THE SEPARATED PORTION WAS MADE, BUT UNABLE TO BRING IT INTO THE 6FR SHEATH. THE SHEATH WAS UPSIZED TO A 16FR AND WAS ABLE TO REMOVE IT SUCCESSFULLY FROM THE PATIENT. A NEW BALLOON AND STENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. 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 16354644 ↗
• MalfunctionJul 27, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MID LAD LESION. DURING INFLATION BELOW RBP, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW 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 15115939 ↗
• InjuryMay 17, 2022Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT DEVICE WAS USED IN A MODERATELY CALCIFIED PROXIMAL RCA. AFTER MULTIPLE INFLATION/DEFLATION AT 16 ATM, THE ANGIOSCULPT GOT STUCK ON THE NON-MANUFACTURER''S GUIDEWIRE AT THE DISTAL RCA, THUS WERE REMOVED AS A UNIT. THE LESION WAS REWIRED AND THE PROCEDURE WAS COMPLETED WITH A NEW 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 14417568 ↗
• MalfunctionNov 17, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED MID CIRC. DURING INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE ANGIOSCULPT WAS REMOVED IN ONE PIECE AND 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 12830080 ↗
• InjuryNov 1, 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 THE PROXIMAL RCA AND UPON REMOVAL, THE BALLOON GOT PINNED TO THE WIRE AND HAD TO BE REMOVED AS A UNIT. THE BALLOON WAS INFLATED 3 TIMES TO 18 ATM (RBP IS 16 ATM). NO ISSUES OBSERVED OR REPORTED DURING DELIVERY. THE LESION WAS REWIRED WITHOUT COMPLICATIONS TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE RETURNED DEVICE ANALYSIS, A DISTAL BOND PEEL WAS OBSERVED. 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. IN ADDITION, THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE DISTAL BOND PEELED, POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12733990 ↗

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.