AngioSculpt PTCA RX Scoring Balloon Catheter 2200-3010Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00813132021207), received between Jun 19, 2018 and Jun 14, 2023 — classified as 2 deaths, 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  INITIAL MDR REPORTED A BALLOON RUPTURE BELOW RBP. HOWEVER, BASED ON THE OBSERVATIONS FROM THE RETURNED PRODUCT ANALYSIS, NO BALLOON RUPTURE WAS OBSERVED AS DESCRIBED IN THE COMPLAINT DETAILS. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130891 ↗
• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID RCA. DURING INFLATION AT 14 ATM, THE BALLOON RUPTURED AND A KINK WAS OBSERVED NEAR THE DISTAL TIP. 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 17080989 ↗
• MalfunctionMar 27, 2023Deflation Problem; Deflation Problem

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID LAD. DURING THE 3RD INFLATION AT 18 ATM (RBP), CONTRAST LEAKED FROM THE GUIDEWIRE EXIT PORT. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON, BUT UNABLE TO REMOVE THE CONTRAST. THE DEVICE WAS PULLED THROUGH THE GUIDE CATHETER, BUT COULD NOT BE RETRIEVED DUE TO RESISTANCE. SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON, BUT ONLY ABLE TO DEFLATE A LITTLE BIT. WITH FORCE APPLIED, THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE TO THE BALLOON UNABLE TO FULLY DEFLATE. THERE IS A POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16623844 ↗
• InjuryNov 16, 2022Material Separation; Material Separation

  THE ANGIOSCULPT CORONARY DEVICE WAS USED OFF-LABEL IN A PERIPHERAL PROCEDURE TO TREAT A CALCIFIED AND TORTUOUS DISTAL AT. UPON REMOVAL, RESISTANCE WAS NOTED AND THE DEVICE SEPARATED AT THE DISTAL SHAFT. ALL PARTS WERE RETRIEVED USING A NON-PHILIPS BALLOON INFLATED TO LOW PRESSURE AND PULLED BACK INTO THE SHEATH. ANGIOGRAM AND FLUOROSCOPY CONFIRMED NO DEVICE FRAGMENT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PHYSICIAN THOUGHT THAT THE TORTUOUS ANGLE CAUSED THE SHAFT ISSUE AND RESISTANCE. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SHAFT SEPARATION REQUIRING MEDICAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15810783 ↗
• MalfunctionJul 11, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED PROXIMAL LAD. DURING INFLATION AT 18 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-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 14983093 ↗
• MalfunctionApr 26, 2022Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID LAD. DURING INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY REPORTED. DURING THE DEVICE EVALUATION, THE BALLOON RUPTURE WAS CONFIRMED AND A DISTAL BOND PEEL WAS OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP AND THE DISTAL BOND PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213657 ↗
• MalfunctionFeb 4, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED PROXIMAL LAD. DURING THE THIRD INFLATION FROM 14 ATM TO 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 13460076 ↗
• DeathAug 13, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  THE PHYSICIAN TREATED A PATIENT WITH MULTIPLE MEDICAL COMORBIDITIES AND SEVERELY CALCIFIED LESIONS. AFTER ATHERECTOMY WITH A ROTA WIRE AND 1.5 MM BURR, THE GUIDEWIRE WAS EXCHANGED FOR A CHOICE PT AND THE ANGIOSCULPT WAS DELIVERED WITH NOT MUCH RESISTANCE. THE ANGIOSCULPT WAS INFLATED TWO TIMES; ONE AT 8 ATM (NOMINAL PRESSURE) FOR FIVE SECONDS, SECOND INFLATION AT 10 ATM FOR 5 SECONDS. THE BALLOON WAS ABLE TO DEFLATE WITH NO ISSUES. UPON REMOVAL, THE ANGIOSCULPT GOT CAUGHT ON THE PATIENT'S ANATOMY. THE PHYSICIAN ATTEMPTED TO PULL SEVERAL TIMES WITH THE GUIDE CATHETER BEING DEEP THROATED WITHOUT SUCCESS. ANOTHER WIRE PASSED THE STUCK ANGIOSCULPT AND WAS PLACED IN A DIAGONAL POSITION. THEN, ANOTHER BALLOON WAS ADVANCED PASSED THE ANGIOSCULPT PARTLY INFLATED TO TRY AND DISLODGE THE ANGIOSCULPT WITHOUT SUCCESS. THE PHYSICIAN FINALLY TUGGED ON THE SHAFT, AND THE SHAFT BROKE INSIDE THE PATIENT AND TRIED SNARING IT WITHOUT SUCCESS. BY THIS TIME THE PATIENT STARTED TO DECOMPENSATE, DROPPING BP, DROPPING O2 SATURATION, AND CODE WAS STARTED. DYE WAS INJECTED, BUT DID NOT SEE A PERFORATION. IT IS LIKELY THAT THE PATIENT DEVELOPED GLOBAL ISCHEMIA FROM THE 3 VESSEL CORONARY DISEASE AS HE WAS NOT

  Patient problems: Foreign Body In Patient; Ischemia; Low Blood Pressure/ Hypotension

  MAUDE report 12321170 ↗
• MalfunctionAug 3, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED MID LAD. DURING THE 2ND INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-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 12268388 ↗
• MalfunctionFeb 9, 2021Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED AND MODERATELY TORTUOUS MID LAD. DURING INFLATION, THE BALLOON RUPTURED AT 14 ATM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11303304 ↗
• MalfunctionJul 27, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS DISTAL LAD. DURING THE FIRST INFLATION AT 10 ATM, THE BALLOON RUPTURED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10329175 ↗
• MalfunctionMay 20, 2020Break; Break

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A CALCIFIED LESION IN THE LAD WITH NO ISSUE DURING ADVANCEMENT. AS THE BALLOON WAS BEING REMOVED FROM THE LESION, RESISTANCE WAS NOTED AND THE SHAFT BROKE IN TWO PIECES. THE SHAFT BROKE OUTSIDE OF THE BODY APPROXIMATELY 1/3 OF THE WAY DOWN FROM THE HUB AND WAS ABLE TO BE REMOVED OFF OF THE GUIDE WIRE. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10077325 ↗
• DeathNov 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT DIED OF CARDIAC ARREST.

  Patient problems: Death

  MAUDE report 8033421 ↗
• MalfunctionJun 19, 2018Detachment Of Device Component; Retraction Problem; Detachment Of Device Component; Retraction Problem

  Patient problems: Atherosclerosis; Ischemic Heart Disease

  MAUDE report 7617709 ↗

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.