AngioSculpt OTW PTA Scoring Balloon Catheter 2332-8040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813132022204), received between Dec 23, 2015 and Mar 27, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Deflation Problem” (3 reports).

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.

• InjuryMar 27, 2024Deflation Problem; Deflation Problem

  THE ANGIOSCULPT CATHETER WAS USED TO TREAT A SEVERELY CALCIFIED LESION. THE CATHETER WAS LOADED OVER AN 0.018" GUIDEWIRE AND ADVANCED THROUGH THE INTRODUCER SHEATH WITH NO RESISTANCE NOTED. THE BALLOON WAS INFLATED ABOVE THE RATED BURST PRESSURE (RBP) TO 16 ATM (RBP 12 ATM) WITH NO ISSUES. HOWEVER, DURING DEFLATION, THE BALLOON WAS UNABLE TO DEFLATE. A CUTDOWN APPROACH WAS PERFORMED TO RETRIEVE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT CATHETER. THERE WAS NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM AND ADVERSE EVENT IS BEING SUBMITTED DUE TO THE BALLOON UNABLE TO DEFLATE, REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989655 ↗
• InjuryJan 14, 2021Deflation Problem; Deflation Problem

  THE DEVICE WAS USED IN A HIGHLY CALCIFIED ILIAC LESION, BUT A STRAIGHT SEGMENT WITH NO TORTUOSITY. AFTER INFLATION, THE ANGIOSCULPT BALLOON WOULD NOT DEFLATE SO THEY PULLED IT BACK TO THE DISTAL ILIAC TO TRY TO GET IT TO DEFLATE. THEN, AN ATTEMPT TO POP THE BALLOON WITH THE BACK END OF A 0.014" GUIDEWIRE WAS PERFORMED; HOWEVER THE BALLOON DID NOT POP. THE 7F INTRODUCER SHEATH WOULD NOT ENCAPSULATE THE ENTIRE BALLOON (THE BALLOON MATERIAL AND THE WIRES WERE HANGING OUTSIDE THE SHEATH), THUS IT WAS DECIDED TO REMOVE AS A UNIT. THE PHYSICIAN PROCEEDED TO MOVE THE SHEATH AND EXPOSED BALLOON OUT THROUGH ANASTOMOSIS. AFTER THE DEVICE WAS REMOVED AS A UNIT, THEY UPSIZED TO A 8FR SHEATH TO COMPLETE STENTING. THE ANGIOGRAM WAS RECEIVED ON (B)(6) 2021. REVIEW OF THE ANGIOGRAM REVEALED THE CASE STARTED WITH AN OMNIFLUSH OR UNIVERSAL FLUSH CATHETER IN THE AORTA FROM THE RIGHT COMMON FEMORAL ACCESS- DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED A CALCIFIED DISTAL AORTA AND A CALCIFIED AND SEVERELY NARROWED LESION IN THE LEFT COMMON ILIAC OSTIUM WITH POST STENOTIC DILATATION OF THE DISTAL COMMON ILIAC ARTERY. AFTER ACCESS WAS OBTAINED FROM THE LEFT FEMORAL, THE LESION WAS TREATED WITH A CSI DIAMONDBA

  Patient problems: Failure to Anastomose

  MAUDE report 11172689 ↗
• InjuryJul 9, 2018Deflation Problem; Deflation Problem

  AN 8 X 40 MM ANGIOSCULPT WAS USED TO TREAT THE AVF. THE BALLOON WAS INFLATED TO 12 ATM AND WAS UNABLE TO DEFLATE. THE TECH PULLED NEGATIVE ON A 20 CC SYRINGE WITH NO AFFECT ON THE BALLOON. THE 20 CC SYRINGE WAS DISCONNECTED AND REPLACED WITH A 60 CC SYRINGE, WITH ONLY A PARTIAL BALLOON DEFLATION NOTED. THE PHYSICIAN USED A NEEDLE TO PUNCTURE SEVERAL HOLES THROUGH THE PATIENT TO DEFLATE THE BALLOON, WHICH RESULTED IN PARTIAL DEFLATION. HOWEVER, WITH FORCE THE ANGIOSCULPT WAS PULLED THROUGH A 7F INTRODUCER SHEATH AND WAS ABLE TO BE REMOVED. NO INJURIES WERE SUSTAINED BY THE PATIENT.

  Patient problems: Atherosclerosis

  MAUDE report 7671929 ↗
• InjuryDec 23, 2015Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method

  THE ANGIOSCULPT WAS USED IN THE ARTERIOVENOUS FISTULA (AVF) AT CEPHALIC VEIN IN THE UPPER LEFT ARM. THE ANGIOSCULPT WAS INFLATED TO 12 ATM FOR 3 MINUTES BUT THE ANGIOGRAPHIC RESULT WAS NOT SATISFACTORY. THE ANGIOSCULPT WAS INFLATED FOR THE SECOND TIME AT 12 ATM FOR 3 MINUTES BUT THE ANGIOGRAPHIC RESULT WAS NOT SATISFACTORY. DURING THE THIRD INFLATION AT 17 ATM (ABOVE THE RATED BURST PRESSURE (RBP) OF 12 ATM) FOR 3 MINUTES, THE BALLOON RUPTURED RADIALLY. IT WAS NOT POSSIBLE TO RETRIEVE THE ANGIOSCULPT THROUGH THE INTRODUCER SHEATH (TERUMO: 6F, 11CM), THUS A SLIGHT SKIN INCISION AT THE PUNCTURE SITE WAS PERFORMED IN ORDER TO REMOVE THE BALLOON AND INTRODUCER SHEATH.

  Patient problems: Test Result; Therapeutic Response, Decreased; Tissue Damage

  MAUDE report 5331903 ↗