AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating 2200-2515-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813132026851), received between Jun 24, 2022 and Nov 17, 2025 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A CORONARY PROCEDURE OF A MODERATELY PLAQUE MID LAD. DURING THE FIRST INFLATION AT 6 ATM (RBP: 16 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 23575828 ↗
• MalfunctionAug 4, 2025Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED IN A CORONARY PROCEDURE OF A MODERATELY CALCIFIED PROXIMAL LAD. AFTER INFLATION, THE CATHETER GOT STUCK IN THE VESSEL, AND THE CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. UPON REMOVAL, THE SCORING ELEMENT WAS UNRAVELED, BUT REMAINED INTACT. THE PROCEDURE WAS COMPLETED WITH THE ANGIOSCULPT CATHETER. 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 22702262 ↗
• InjuryApr 23, 2025Entrapment of Device; Entrapment of Device

  AN ANGIOSCULPT CATHETER WAS USED TO TREAT A SEVERELY CALCIFIED DISTAL LAD. PRIOR TO USE OF THE ANGIOSCULPT, A STENT WAS PLACE IN BETWEEN TWO EXISTING STENTS (DISTAL AND PROXIMAL LAD). A XIENCE DRUG-ELUTING STENT (DES) WAS DEPLOYED IN THE MID LAD TO BRIDGE THE GAP, AND THEN THE ANGIOSCULPT WAS INFLATED AT THE DISTAL STENT. THE ANGIOSCULPT DEFLATED WITH NO ISSUES; HOWEVER, DURING PULLBACK, THE ANGIOSCULPT GOT CAUGHT ON THE XIENCE, CAUSING IT TO CRUMBLE IN A BALL. A COUPLE TECHNIQUES WERE MADE TO ATTEMPT REMOVAL OF BOTH THE ANGIOSCULPT AND XIENCE BUT WERE UNSUCCESSFUL. THE ANGIOSCULPT SHAFT WAS CUT AND THE PATIENT WAS TRANSFERRED TO SURGERY. A BYPASS TO THE LAD WAS PERFORMED TO SAVE THE VESSEL, BUT THE ANGIOSCULPT AND XIENCE REMAINED IN THE PATIENT. THE PATIENT WAS DOING WELL AND IN RECOVERY. FIVE DAYS LATER, THE PATIENT'S BLOOD PRESSURE DROPPED SUDDENLY AND DID NOT RECOVER. PER PHILIPS CLINICAL ASSESSMENT, IT IS SUSPECTED THAT THE CAUSE OF DEATH WAS RELATED TO COMPLICATIONS OF THE BYPASS SURGERY. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO DEVICE ENTRAPMENT, REQUIRING INTERVENTION BUT RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21890388 ↗
• MalfunctionJun 24, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A MODERATELY CALCIFIED MID LAD. DURING THE 2ND INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A STENT PLACEMENT. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802558 ↗

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.