AngioSculpt PTCA RX Scoring Balloon Catheter 2200-2515Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813132021184), received between Mar 25, 2019 and Jan 4, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 4, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID LAD ARTERY. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE IT IS UNKNOWN IF THE BALLOON RUPTURED ABOVE THE RATED BURST PRESSURE (RBP). THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097613 ↗
• MalfunctionOct 12, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED FOR PRE-DILATION ON A CALCIFIED MID LAD. AFTER ADVANCING THE ANGIOSCULPT TO THE LESION, THE BALLOON WAS INFLATED TO NOMINAL PRESSURE (8 ATM) BUT DID NOT INFLATE AS EXPECTED UNDER FLUOROSCOPY. UPON REMOVAL OF THE ANGIOSCULPT, A BALLOON RUPTURE WAS OBSERVED. 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 15592232 ↗
• MalfunctionDec 29, 2019Break; Break

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE PROXIMAL LAD, BUT WAS UNABLE TO ADVANCE DISTALLY TO THE LESION. DURING WITHDRAWAL, RESISTANCE WAS NOTED AND THE DEVICE WAS UNABLE TO BE REMOVED FROM THE LESION. AS A RESULT, THE DEVICE SNAPPED IN TWO PIECES, BUT WAS ABLE TO BE REMOVED FROM THE PATIENT, LEAVING THE GUIDE WIRE IN PLACE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9528624 ↗
• MalfunctionNov 4, 2019Stretched; Stretched

  DURING USE IN PATIENT, THE ANGIOSCULPT DEVICE WAS DEFECTIVE. THE HYPOTUBE WAS STRETCHED OUT AND BECAME FLOPPY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE AND NO PATIENT INJURY REPORTED. DURING THE RETURNED DEVICE EVALUATION ON 10/10/2019, A DISTAL BOND PEEL WAS OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9272687 ↗
• MalfunctionMar 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING USE IN PATIENT, THE SHAFT BROKE. NO PIECE OF THE ANGIOSCULPT DEVICE WAS RETAINED IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449920 ↗

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.