AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating 2249-60200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00813132021573), received between Sep 16, 2019 and Feb 7, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2025Difficult to Remove; Material Separation; Failure to Deflate; Difficult to Remove; Material Separation; Failure to Deflate

  AN ANGIOSCULPT CATHETER WAS USED TO TREAT A MODERATELY CALCIFIED PROXIMAL LESION. THE CATHETER WAS LOADED OVER A NON-PHILIPS GUIDEWIRE WHERE RESISTANCE WAS ENCOUNTERED. THE BALLOON WAS INFLATED TO 10 ATM IN THE SFA AND POPLITEAL WITH NO ISSUES, BUT WAS UNABLE TO DEFLATE; THUS, A NEEDLE WAS USED TO POP THE BALLOON THROUGH THE SKIN. DURING REMOVAL, FURTHER RESISTANCE WAS NOTED, AND THE SCORING ELEMENT SEPARATED, WHILE THE REST OF THE CATHETER WAS REMOVED TOGETHER WITH THE GUIDEWIRE. THEN, A SNARE WAS USED TO ATTEMPT REMOVAL BUT WAS UNSUCCESSFUL. THEREFORE, THE PATIENT WAS TRANSFERRED TO THE OR FOR SURGICAL REMOVAL. IMAGING CONFIRMED THAT NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, AND THE PATIENT IS DOING WELL WITH NO INJURIES REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE BALLOON DEFLATION AND SCORING ELEMENT SEPARATION, REQUIRING ADDITIONAL INTERVENTION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21339797 ↗
• MalfunctionJan 3, 2023Material Rupture; Sharp Edges; Material Rupture; Sharp Edges

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED DISTAL SFA AND PROXIMAL POP. DURING INFLATION, THE BALLOON RUPTURED AT 6 ATM AND THE BALLOON AND SHEATH WERE REMOVED TOGETHER. A NEW SHEATH AND NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE RETURNED PRODUCT ANALYSIS, THE BALLOON RUPTURE WAS CONFIRMED AND ONE SCORING ELEMENT STRUT WAS DETACHED WITH A SHARP EDGE OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED FOR A BALLOON RUPTURE BELOW RBP AND THE SHARP EDGE OBSERVED. THE BALLOON RUPTURE IS BEING REPORTED CONSERVATIVELY, AND THE SHARP EDGE HAS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092048 ↗
• MalfunctionNov 18, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT AN AT PERIPHERAL LESION TO IMPROVE BLOOD FLOW TO THE LEFT FOOT. DURING INFLATION, THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. UPON REMOVAL, IT WAS NOTED THAT THE BALLOON DETACHED FROM THE SHAFT, BUT REMAINED INTACT TO THE 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 15829052 ↗
• InjurySep 30, 2022Entrapment of Device; Entrapment of Device

  THE ANGIOSCULPT DEVICE WAS USED IN A MODERATELY CALCIFIED MID SFA IN-STENT STENOSIS. THE WIRE CROSSED THE LESION AND A 2.0 LASER WAS USED. WHEN THE ANGIOSCULPT WAS INSERTED, THE DEVICE FULLY INFLATED AND DEFLATED WITH NO ISSUES. AS THE DEVICE WAS BEING REMOVED, IT WAS NOTICED THAT THERE WAS A KINK HALFWAY ACROSS THE BALLOON AND THE SCORING ELEMENT APPEARED UNORGANIZED, PREVENTING REMOVAL FROM THE 6F SHEATH. THEREFORE, THE DEVICE AND SHEATH WERE REMOVED TOGETHER AS A UNIT, KEEPING THE GUIDEWIRE IN PLACE. A NEW 6F SHEATH WAS INSERTED OVER THE WIRE FOR HEMOSTASIS AND AN ANGIOGRAM WAS PERFORMED AFTER THE SHEATH EXCHANGE TO VERIFY NO BLEEDING. THERE WAS NO INJURY TO THE VESSEL AFTER THE ANGIOGRAM WAS PERFORMED. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE ANGIOSCULPT GOT STUCK INSIDE A NON-MANUFACTURER''S INTRODUCER SHEATH AND WERE REMOVED AS A UNIT. PLACEMENT OF A NEW SHEATH WAS NECESSARY TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15522051 ↗
• InjuryAug 22, 2022Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  FROM THE ARM ACCESS, THE PHYSICIAN¿S TARGET LESION WAS THE SFA, BUT WAS UNABLE TO REACH THE SFA; THEREFORE, THE BALLOON WAS INFLATED DISTAL AT THE MID COMMON ILIAC ARTERY. THE BALLOON WAS INFLATED TO 6 ATM AND DEFLATED. THEN THE CATHETER WAS ADVANCED TO TREAT FURTHER UP THE LESION, BUT GOT STUCK. THE BALLOON WAS ATTEMPTED TO BE INFLATED, BUT THE PRESSURE WOULD NOT INCREASE, THUS IT WAS ASSUMED THAT THE BALLOON HAD RUPTURED. IN ORDER TO REMOVE FROM THE PATIENT, THE HUB WAS CUT OFF TO ADVANCE A LONG 8F SHEATH OVER IT, BUT WOULD NOT PASS BEYOND THE MID-BALLOON. THE PHYSICIAN DECIDED TO ACCESS THE RIGHT GROIN TO SNARE THE WIRE FROM BELOW. THE GUIDE WIRE AND THE DISTAL PORTION OF THE DEVICE WAS REMOVED THROUGH THE FEMORAL SHEATH AND THE PROXIMAL SHAFT WAS REMOVED FROM THE ARM ACCESS. UPON REMOVAL, THE BALLOON WAS OBSERVED TO BE DAMAGED. THE PATIENT WAS FINE. THE PHYSICIAN STATED THIS IS NOT DUE TO A FAILURE WITH THE DEVICE, BUT LIKELY DUE TO THE SEVERELY CALCIFIED LESION. THE PROCEDURE WAS COMPLETED WITH A BALLOON-EXPANDABLE STENT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A BALLOON RUPTURE AND THE CATHETER GETTING STUCK REQUIRING ADDITIONAL INTERVENTION TO COMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272061 ↗
• InjuryOct 28, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  THE ANGIOSCULPT DEVICE WAS INSERTED IN ISR OF THE MID SFA WITH NO ISSUES. THEN, THE BALLOON WAS INFLATED ABOVE RBP AND THE BALLOON RUPTURED. UPON REMOVAL, RESISTANCE WAS NOTED AND THE BALLOON PORTION GOT CAUGHT IN THE INTRODUCER SHEATH. IN ORDER TO REMOVE FROM THE PATIENT, SOME DEGREE OF FORCE WAS APPLIED, RESULTING IN A DEVICE SEPARATION. THE DISTAL PORTION OF THE BALLOON WAS LEFT IN THE PATIENT; HOWEVER IT WAS ABLE TO BE REMOVED BY PERFORMING A CUT DOWN APPROACH. NO PIECE OF THE ANGIOSCULPT DEVICE WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A LASER DEVICE.

  Patient problems: Injury

  MAUDE report 10752683 ↗
• InjuryAug 5, 2020Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  THE ANGIOSCULPT DEVICE WOULD NOT CROSS IN A MODERATELY CALCIFIED DISTAL ANTERIOR TIBIAL ARTERY. UPON REMOVAL, THE BALLOON WAS UNABLE TO COME OUT THROUGH THE SHEATH. THE GUIDE WIRE REMAINED IN THE PATIENT, WHILE THE BALLOON AND SHEATH WERE REMOVED AS A UNIT. PLACEMENT OF A NEW SHEATH AND A NEW ANGIOSCULPT DEVICE WAS REQUIRED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10369088 ↗
• MalfunctionSep 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ANGIOSCULPT BALLOON WAS INFLATED TO 8 ATM WITH NO ISSUES. UPON REMOVAL, RESISTANCE WAS NOTED, THUS FORCE WAS APPLIED AND THE DISTAL SHAFT SEPARATED. THE SHEATH, GUIDE WIRE, AND DISTAL SHAFT WERE REMOVED AS A UNIT. NO PIECE OF THE ANGIOSCULPT DEVICE WAS RETAINED IN THE PATIENT. NO PATIENT INJURY REPORTED AND NO ADDITIONAL EQUIPMENT OR INTERVENTION WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9072210 ↗