AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating 2200-2510-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813132026844), received between Jul 20, 2022 and May 14, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Material Separation; Material Separation

  AN ANGIOSCULPT CATHETER WAS USED IN A CORONARY PROCEDURE TO TREAT A MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY. THE ANGIOSCULPT WAS INFLATED MULTIPLE TIMES OVER THE RATED BURST PRESSURE (RBP), AND DID NOT FULLY DEFLATE THE BALLOON, PRIOR TO REMOVING. DURING REMOVAL, THE ANGIOSCULPT GOT STUCK INSIDE THE NON-PHILIPS GUIDE EXTENSION CATHETER AND SEPARATED BUT WAS ABLE TO BE REMOVED ALL TOGETHER. IMAGING CONFIRMED THAT NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. UPON REMOVAL, THE SEPARATED ANGIOSCULPT PORTION WAS FORCIBLY REMOVED TO CHECK THAT ALL PARTS WERE PRESENT, CAUSING DAMAGE TO THE GUIDE EXTENSION CATHETER. THE PROCEDURE WAS ABANDONED WITH NO PATIENT INJURY REPORTED. POST PROCEDURE, THE PHYSICIAN ACKNOWLEDGED THAT DUE TO OPERATOR ERROR (INFLATING BALLOON ABOVE RBP), RESULTED IN THE DAMAGE OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO DISTAL SHAFT SEPARATION, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022481 ↗
• MalfunctionMar 28, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED DISTAL CIRCUMFLEX ARTERY. DURING INFLATION AT 16 ATM (RBP), THE BALLOON RUPTURED (MDR 3005462046-2025-00011). A NEW ANGIOSCULPT WAS THEN USED; HOWEVER, 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 (14 ATM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720025 ↗
• MalfunctionFeb 19, 2025Entrapment of Device; Entrapment of Device

  ADDITIONAL INFORMATION CONFIRMED THAT THE ANGIOSCULPT DEVICE WAS REMOVED BY ITSELF. THEREFORE, THIS IS NO LONGER REPORTABLE FOR REMOVAL AS A SYSTEM. THERE IS NO POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415947 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED DISTAL RCA. DURING INFLATION AT 14 ATM, 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 18530016 ↗
• MalfunctionNov 1, 2023Sharp Edges; Sharp Edges

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY. THE ANGIOSCULPT WAS LOADED OVER A 0.014¿ BMW GUIDEWIRE AND INSERTED THROUGH THE 6F GUIDEZILLA GUIDE CATHETER WITH NO RESISTANCE. THE ANGIOSCULPT WAS INFLATED AND DEFLATED WITH NO ISSUES. DURING REMOVAL, RESISTANCE WAS NOTED AND COULD NOT BE REMOVED FROM THE GUIDE CATHETER; THEREFORE, EVERYTHING WAS REMOVED AS A UNIT. UPON REMOVAL, IT WAS OBSERVED THAT THE BALLOON AND THE OUTER SHAFT OF THE ANGIOSCULPT WAS SHEARED BUT REMAINED INTACT. ADDITIONALLY, THE DISTAL PORTION OF THE GUIDEWIRE HAD SEPARATED AND WAS LOCATED ON THE FLOOR, AND THE TIP OF THE GUIDE CATHETER WAS DAMAGED. FLUOROSCOPY CONFIRMED THAT NOTHING WAS LEFT INSIDE THE PATIENT. A NEW GUIDEZILLA GUIDE CATHETER, NEW BMW GUIDEWIRE, AND A NC BALLOON WERE PLACED TO COMPLETE THE PROCEDURE. HOWEVER, DAMAGE WAS OBSERVED ON THE NC BALLOON AND WAS REPLACED WITH ANOTHER NC BALLOON, BUT THE SAME DAMAGE WAS OBSERVED. THE PHYSICIAN BELIEVES THAT THE GUIDE CATHETER GOT MANGLED ON THE TAVR CAGE (COREVALVE) DURING INSERTION AND SUBSEQUENTLY DAMAGED THE DISTAL TIP OF THE GUIDE CATHETER; WHICH CAUSED THE DAMAGE TO ALL THE DEVICES PASSING THROUGH. THE PROCEDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049547 ↗
• MalfunctionSep 22, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MID RCA LESION. DURING INFLATION AT 12 ATM FOR 10 SECONDS, 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 15465323 ↗
• MalfunctionJul 20, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID LAD. DURING THE FIFTH 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 15067999 ↗

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.