AngioSculpt PTCA RX Scoring Balloon Catheter 2200-3015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813132021214), received between Mar 29, 2018 and Aug 23, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2023Material Rupture; Material Rupture

  BASED ON THE DEVICE EVALUATION, A SEMI BALLOON RADIAL TEAR WAS OBSERVED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE TO THE SEMI BALLOON RADIAL TEAR; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605213 ↗
• InjuryJul 18, 2022Deflation Problem; Entrapment of Device; Deflation Problem; Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED IN THE CORONARY ARTERY TO TREAT THE LAD AND DIAGONAL BRANCH. THE CATHETER WAS ADVANCED OVER A NON-MANUFACTURER¿S GUIDE WIRE WITH NO ISSUES REPORTED. POST ANGIOPLASTY, THE CATHETER BECAME ENTANGLED WITH THE GUIDE WIRE; THEREFORE, WAS REMOVED AS A UNIT. UPON REMOVAL, THE BALLOON APPEARED TO BE HALF-DEPLOYED AND DID NOT REWRAP FULLY TO ITS ORIGINAL POSITION, WHICH LIKELY CAUSED THE ENTANGLEMENT. THE LESION WAS REWIRED AND COMPLETED THE PROCEDURE WITH A NON-ANGIOSCULPT BALLOON. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING REPORTED DUE TO THE BALLOON UNABLE TO FULLY DEFLATE AND PLACEMENT OF A NEW GUIDEWIRE WAS NECESSARY TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047013 ↗
• MalfunctionNov 4, 2020Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED WITH A GUIDE WIRE AND A BUDDY WIRE TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID CX INTO THE OM ARTERY. DURING THE THIRD INFLATION WHEN TRYING TO GO ABOVE 16 ATM, THE SHAFT RUPTURED AND THE BALLOON WAS UNABLE TO FULLY DEFLATE. THE DEVICE WAS REMOVED FROM THE GUIDE WIRE WITH NO ISSUES. AN IVUS WAS PERFORMED IMMEDIATELY, AND CONFIRMED NO CORONARY DISSECTION OCCURRED. THE PROCEDURE WAS COMPETED WITH A STANDARD BALLOON, AND THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE ENTIRE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10785324 ↗
• InjuryMar 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT WAS ADMITTED WITH SLEEP APNEA, PNEUMONIA, MADE ENZYMES, AND DIAGNOSED WITH SEVERE MID LAD DISEASE. THE PHYSICIAN PREDILATED THE LESION WITH AN APEX BALLOON. TO MAKE IT "LOOK NICER," AN ANGIOSCULPT DEVICE WAS ADVANCED WITH NO PROBLEM MANEUVERING THE BALLOON DOWN TO THE MID LAD. THE BALLOON WAS INFLATED MULTIPLE TIMES BELOW RBP (18 ATM), WITH NO ISSUES. DURING WITHDRAWAL, THE BALLOON GOT STUCK IN THE PROXIMAL LAD AND NOT IN THE ORIGINAL LESION. NO STENT WAS PRESENT IN THE PROXIMAL LAD WITH NOT MUCH CALCIUM OBSERVED. THE PHYSICIAN MOVED THE GUIDING CATHETER UP TO THE BALLOON, TUGGED IT 2-3 TIMES WITH SLIGHT RESISTANCE, ALONG WITH SEVERAL INFLATION, BUT THE DEVICE SEPARATED IN 2 PIECES AND RETAINED IN THE PATIENT. THE PATIENT WENT INTO SURGERY AND GOT A BYPASS TO THE LAD. DUE TO THE SLEEP APNEA AND PNEUMONIA, THE PATIENT GOT TRACHEAL POST-OP. UPON REMOVAL OF THE PROXIMAL SHAFT, THE PHYSICIAN COMPARED IT TO AN UNUSED ANGIOSCULPT DEVICE TO MEASURE THE LENGTH OF THE RETAINED PORTION. THE PHYSICIAN BELIEVED THE DEVICE SEPARATED AT THE DISTAL TRANSITION POINT, AND APPROXIMATELY 6-7 INCHES WAS RETAINED IN THE BODY.

  Patient problems: Apnea; Device Embedded In Tissue or Plaque; Pneumonia

  MAUDE report 9894900 ↗
• MalfunctionOct 3, 2019Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  UPON INITIAL ADVANCEMENT INTO THE BODY, A ''KINK'' WAS NOTED AT THE PROXIMAL SHAFT. AT THAT POINT, THE ADVANCEMENT STOPPED AND ATTEMPTED TO SLIGHTLY INFLATE THE BALLOON (TO TEST IT), TO SEE IF THE BALLOON WAS PATENT, BUT IT WAS NOT. THE BALLOON WAS DEFLATED AND DURING WITHDRAWAL, THERE WAS LITTLE TO NO RESISTANCE NOTED, HOWEVER, THE STEM (SHAFT) FULLY BROKE AT THE KINK. THE DISTAL PORTION WAS STILL INSIDE THE BODY, BUT THE PROXIMAL END WAS OUTSIDE AND ABLE TO BE RETRIEVED. THE RESIDUAL BALLOON STEM (DISTAL SHAFT) WAS REMOVED WITH NO EXCESSIVE FORCE APPLIED. THE GUIDE WIRE REMAINED IN PLACE AND A DIFFERENT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9154134 ↗
• InjuryMar 29, 2018Detachment Of Device Component; Detachment Of Device Component

  Patient problems: Atherosclerosis; Ischemic Heart Disease

  MAUDE report 7384191 ↗

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.