AngioSculpt PTCA RX Scoring Balloon Catheter 2200-3515Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813132021245), received between Dec 12, 2018 and Jan 11, 2023 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2023Sharp Edges; Sharp Edges

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RCA. THERE WERE NO ISSUES DURING INSERTION; HOWEVER, AFTER THE 1ST INFLATION AND DEFLATION, THE WIRE WAS FLIMSY. THE PHYSICIAN REMOVED THE DEVICE AND A KINKED SHAFT WITH A SHARP EDGE WAS OBSERVED. A NEW ANGIOSCULPT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142170 ↗
• InjuryJul 14, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED PROXIMAL RCA. PRIOR TO THE ANGIOSCULPT, A ROTABLATION DEVICE WAS USED. THE ANGIOSCULPT WAS INFLATED MULTIPLE TIMES AND DURING THE 4TH INFLATION AT 16 ATM FOR 12 SECONDS, THE BALLOON BURST. UPON REMOVAL, THE DEVICE WAS CAUGHT IN THE PATIENT¿S ANATOMY AND UNABLE TO BE REMOVED. WITH MUCH FORCE APPLIED, A PORTION OF THE BALLOON SEPARATED RADIALLY IN THE PATIENT. THE PATIENT WAS IN STABLE CONDITION, BUT WAS TRANSFERRED BY HELICOPTER TO ANOTHER HOSPITAL FOR BYPASS. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE BALLOON RUPTURED RADIALLY AND REQUIRED SURGICAL INTERVENTION (BYPASS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15020128 ↗
• MalfunctionOct 25, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE PROXIMAL LAD. DURING INFLATION AT 10 ATM, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED OVER THE WIRE IN ONE PIECE AND THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE A SEMI-RADIAL BALLOON TEAR WAS CONFIRMED DURING THE RETURNED PRODUCT ANALYSIS. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694326 ↗
• MalfunctionJun 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, RESISTANCE WAS NOTED DURING DELIVERY OF THE ANGIOSCULPT DEVICE. UPON REMOVAL, THE SHAFT BROKE IN TWO PIECES AND THE DEVICE WAS REMOVED INTACT TO THE GUIDE WIRE WITH NO ADDITIONAL INTERVENTION. THE PROCEDURE WAS ABORTED DUE TO THE PATIENT NOT BEING A GOOD CANDIDATE AND THE PROCEDURE WAS COMPLETED FROM AN INTERVENTIONAL STANDPOINT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980177 ↗
• MalfunctionDec 12, 2018Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

  THE ANGIOSCULPT DEVICE WAS INFLATED/DEFLATED MULTIPLE TIMES AT 18 ATM. DURING THE LAST INFLATION, THE SHAFT SEEMED TO HAVE DETACHED FROM THE CATHETER AND WAS UNABLE TO FULLY DEFLATE. THE DEVICE WAS REMOVED INTACT WITH NO RESISTANCE AND NO INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155455 ↗

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.