AngioSculpt PTCA RX Scoring Balloon Catheter 2200-2510Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00813132021177), received between Jul 12, 2018 and Aug 12, 2022 — classified as 3 injuries, 7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2022Material Rupture; 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 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 15220875 ↗
• MalfunctionJun 29, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED MID 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 BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861827 ↗
• MalfunctionNov 23, 2021Material 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 12862818 ↗
• MalfunctionAug 27, 2020Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SLIGHTLY CALCIFIED MID LAD. DURING INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459680 ↗
• InjuryJan 21, 2020Entrapment of Device; Retraction Problem; Unraveled Material; Entrapment of Device; Retraction Problem; Unraveled Material

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED RCA WITH SLIGHT VESSEL TORTUOSITY. DURING INSERTION, THE SCORING ELEMENT GOT CAUGHT ON THE GUIDE WIRE AND THE SCORING ELEMENT STARTED TO UNRAVEL WITHIN THE CORONARY ARTERY. THE DEVICE COULD ONLY BE REMOVED AS A WHOLE SYSTEM, THUS REWIRING OF THE LESION WAS REQUIRED TO COMPLETE THE PROCEDURE WITH OTHER INTERVENTIONAL BALLOONS AND STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9613436 ↗
• InjuryDec 29, 2019Break; Break

  THE ANGIOSCULPT DEVICE WAS INFLATED AND DEFLATED WITH NO ISSUES IN THE PROXIMAL LAD. DURING WITHDRAWAL, RESISTANCE WAS NOTED AND THE DEVICE WAS UNABLE TO BE REMOVED FROM THE LESION. WHEN THE PHYSICIAN TRIED TO PULL IT OUT, THE DEVICE SNAPPED IN TWO PIECES. AS A RESULT, CABG WAS PERFORMED TO RETRIEVE THE DISTAL PORTION OF THE DEVICE. NO PIECE OF THE DEVICE WAS RETAINED IN THE PATIENT.

  Patient problems: Injury

  MAUDE report 9528623 ↗
• MalfunctionMay 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS HAVING A HARD TIME TRACKING THE VESSEL. WHEN ADVANCING THE ANGIOSCULPT DEVICE, APPROXIMATELY 4 INCHES FROM THE HUB WAS BENT. THE PHYSICIAN TRIED TO ADVANCE THE DEVICE A SECOND TIME, WHEN THE HUB BROKE OFF IN THE PHYSICIAN¿S HAND. THE DEVICE WAS RETRIEVED SUCCESSFULLY AND A NEW ANGIOSCULPT DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8612722 ↗
• InjuryAug 16, 2018Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  PHYSICIAN TREATED A HIGH-RISK PATIENT WITH A SUB-TOTAL STENOSIS IN THE LM, LONG STENOSIS IN THE PROXIMAL LAD, AND OCCLUDED RCA. AFTER SEVERAL BALLOON DILITATION ATTEMPTS IN THE SIGNIFICANTLY CALCIFIED LAD USING A 2.75 MM NC BALLOON, THE PHYSICIAN WAS UNABLE TO DELIVER A STENT. THE PHYSICIAN THEN DECIDED TO USE A 2.5 MM X 10 MM ANGIOSCULPT PTCA THAT WAS SUCCESSFULLY DELIVERED TO THE LAD. THE BALLOON WAS INFLATED SEVERAL TIMES TO 10 ATM, STEP-WISE 2 ATM. DURING WITHDRAWAL, THE ANGIOSCULPT GOT STUCK IN THE PROXIMAL LAD AND WAS UNABLE TO RETRIEVE. THE PHYSICIAN INFLATED THE BALLOON SEVERAL TIMES AT A LOW PRESSURE OF 4 ATM WITHOUT SUCCESS. THE GUIDE WIRE WAS REMOVED FROM THE ANGIOSCULPT WITHOUT FRICTION. THE PHYSICIAN THEN ATTEMPTED TO PULL THE CATHETER BACK, BUT THE SHAFT SEPARATED AND THE DISTAL PART OF THE ANGIOSCULPT REMAINED IN THE PROXIMAL LAD AND LM. THE PHYSICIAN THEN INTUBATED THE VESSEL WITH A GUIDE CATHETER AND USED A 2.5 MM SC BALLOON TO "JAIL" THE ANGIOSCULPT AND WAS ABLE TO BE REMOVED. THE VESSEL WAS THEN REWIRED AND MANAGED TO INTUBATE THE LAD SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. NO PIECE OF THE ANGIOSCULPT WAS RETAINED IN THE PATIENT. THE

  Patient problems: Atherosclerosis; Ischemic Heart Disease

  MAUDE report 7791619 ↗
• MalfunctionJul 17, 2018No Display/Image; No Display/Image

  PHYSICIAN WAS UNABLE TO SEE THE MARKER BANDS DURING USE IN PATIENT.

  Patient problems: Atherosclerosis; Ischemic Heart Disease

  MAUDE report 7693764 ↗
• MalfunctionJul 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED PERONEAL ARTERY. WHEN THE DEVICE WAS ADVANCED OVER THE .014 WIRE AND THROUGH THE 6F SHEATH, THE PROXIMAL HYPOTUBE BROKE ABOUT 10-12 CM FROM THE PROXIMAL HUB. THE LOCATION OF THE BREAK OCCURRED OUTSIDE OF THE BODY, BEFORE ENTRY INTO THE SHEATH. THE PROXIMAL AND DISTAL PIECE OF THE DEVICE WERE BOTH RETRACTED BACK OVER THE WIRE AND A REPLACEMENT DEVICE WAS USED SUCCESSFULLY WITHOUT INCIDENT.

  Patient problems: Atherosclerosis; Peripheral Vascular Disease

  MAUDE report 7681890 ↗

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.