AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating 2200-3515-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00813132026936), received between Feb 1, 2021 and Mar 31, 2026 — classified as 4 injuries, 5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Deflation Problem

  THE ANGIOSCULPT DEVICE WAS USED FOR A THERAPEUTIC CORONARY PROCEDURE IN A SEVERELY CALCIFIED RCA. DURING USE, THE BALLOON WAS INFLATED TO 14 ATM, AND AFTER SEVERAL INFLATIONS, THE BALLOON WAS UNABLE TO DEFLATE, DESPITE MULTIPLE STANDARD TECHNIQUES (NEGATIVE PRESSURE, ALTERNATE INFLATORS, SALINE INFLATION). AN ATTEMPT WAS MADE TO PUNCTURE THE NEEDLE INTRAVASCULARLY, BUT ULTIMATELY, THE SHAFT WAS CUT, AND A GUIDELINER WAS ADVANCED OVER THE SHAFT. ROTAGLIDE WAS INJECTED FOR LUBRICATION, AND THE CATHETER WAS SUCCESSFULLY REMOVED VIA GUIDELINER-ASSISTED EXTRACTION WITHOUT LOSS OF WIRE POSITION. THE PROCEDURE WAS COMPETED WITH NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO BALLOON UNABLE TO DEFLATE, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745874 ↗
• MalfunctionOct 22, 2025Deflation Problem; Deflation Problem

  THE ANGIOSCULPT CATHETER WAS USED IN A CORONARY PROCEDURE. DURING USE, THE BALLOON WAS INFLATED FOR APPROX. 20 MINUTES WITH NO ISSUES, AND UP TO 18 ATM FOR THE LAST INFLATION. THE BALLOON WAS DEFLATED ON FLUOROSCOPY BUT COULD NOT BE REMOVED DESPITE TRACTION AND COUNTERTRACTION. THE BALLOON WAS REINFLATED TO 6 ATM, BUT WAS NOW UNABLE TO DEFLATE. NEGATIVE SUCTION WAS APPLIED TO DEFLATE THE BALLOON, SALINE WAS ADMINISTERED TO DECREASE VISCOSITY, AND PASSED A WIRE INTO THE BALLOON LUMEN, BUT NONE WORKED. ANOTHER WIRE AND A 2.0 BALLOON WAS ADVANCED ALONGSIDE THE FIRST HALF OF THE INFLATED BALLOON, GENTLY PULLED BACK, AND TRIED TO PUNCTURE THE BALLOON WITH THE STIFF END OF THE WIRE, BUT WAS NOT POSSIBLE TO REMOVE. THEREFORE, EVERYTHING WAS PULLED BACK TO THE RADIAL SHEATH, AND WAS REMOVED IN ONE PIECE. UPON REMOVAL, THE BALLOON WAS SLIGHTLY INFLATED AND THE SCORING ELEMENT WAS DAMAGED. THE SCORING ELEMENT DETACHED FROM ONE END OF THE BALLOON BUT REMAINED INTACT ON THE OPPOSITE END. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE BALLOON UNABLE TO DEFLATE; REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361181 ↗
• InjuryApr 3, 2025Material Separation; Material Separation

  AN ANGIOSCULPT DEVICE WAS USED IN A CORONARY PROCEDURE. WHEN THE ANGIOSCULPT WAS ADVANCED TO THE LESION, RESISTANCE WAS NOTED BUT ABLE TO BE USED. DURING REMOVAL, FURTHER RESISTANCE WAS ENCOUNTERED, IN WHICH FORCE WAS APPLIED IN ORDER TO REMOVE FROM THE PATIENT. HOWEVER, THE SHAFT SEPARATED, BUT WAS SUCCESSFULLY REMOVED BY TRAPPING THE SEPARATED PORTION WITH A BALLOON. IMAGING CONFIRMED NO DEVICE FRAGMENTS WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM AND ADVERSE EVENT IS BEING SUBMITTED DUE TO SHAFT SEPARATION, REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768000 ↗
• InjuryJul 22, 2023Difficult to Remove; Difficult to Remove

  DETAILS OBTAINED FROM THE FRANCE COMPETENT AUTHORITY ON 10JUL2023: DURING DILATATION OF THE CIRCUMFLEX ARTERY, THE ANGIOSCULPT BALLOON WAS INFLATED, BUT DID NOT DEFLATE AND WAS OCCLUSIVE IN THE ARTERY. ADDITIONAL INFORMATION OBTAINED FROM THE PHILIPS REPRESENTATIVE ON 20JUL2023: THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY FIBROUS PROXIMAL CIRCUMFLEX ARTERY. THE BALLOON WAS INFLATED TO 10 ATM AND DEFLATED WITH NO ISSUES. DURING REMOVAL, DIFFICULTY WAS NOTED DUE TO THE OLD STENT AND ANGULATION. A PARALLEL WIRE AND ANOTHER BALLOON WERE USED TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY WAS REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE RETRACTION PROBLEM, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375402 ↗
• MalfunctionJan 18, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY TORTUOUS VESSEL AND SLIGHTLY CALCIFIED DISTAL RCA. DURING INFLATION, THE BALLOON RUPTURED UNDER 8 ATM. A NON-ANGIOSCULPT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 16200315 ↗
• InjuryMay 17, 2022Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT DEVICE WAS USED IN THE PROXIMAL LAD. UPON REMOVAL, THE ANGIOSCULPT GOT STUCK ON THE NON-MANUFACTURER'S GUIDEWIRE, THUS WERE REMOVED AS A UNIT. THE LESION WAS REWIRED AND THE PROCEDURE WAS COMPLETED WITH A NSE 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 14418421 ↗
• MalfunctionMar 3, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED RCA. DURING THE THIRD INFLATION AT 16 ATM FOR 5 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 AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660596 ↗
• MalfunctionDec 28, 2021Material Rupture; Material Rupture

  THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101442 ↗
• MalfunctionFeb 1, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED PROXIMAL LAD. DURING INFLATION AT RBP, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A BALLOON AND A PLANNED STENT PLACEMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11263184 ↗

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.