AngioSculpt PTCA RX Scoring Balloon Catheter 2200-2010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813132021146), received between Jan 15, 2019 and Jul 11, 2022 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionJul 11, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED MID LAD. DURING INFLATION AT 17 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 14983068 ↗
• MalfunctionJan 21, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID LAD. DURING THE SECOND 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 13323225 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED TO MONITOR THE GROIN COMPLICATION. AFTER TWO NIGHTS, THE PATIENT HAD A POSITIVE OUTCOME AND WAS SENT HOME. TWO WEEKS POST PROCEDURE, THE PHYSICIAN INDICATED THE PATIENT IS DOING FINE.

  Patient problems: Hematoma

  MAUDE report 9863013 ↗
• MalfunctionJan 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ANGIOSCULPT DEVICE WAS USED IN A PATIENT WITH SEVERE CORONARY ARTERY DISEASE. DURING DELIVERY TO THE HEAVILY CALCIFIED LAD LESION, RESISTANCE WAS NOTED. UPON REMOVAL, WITH THE DISTAL PORTION STILL IN THE PATIENT, THE SHAFT SEPARATED AT THE PROXIMAL END NEAR THE HUB (OUTSIDE OF THE BODY). NO PIECE OF THE ANGIOSCULPT DEVICE WAS RETAINED IN THE PATIENT. THE VESSEL WAS TOO CALCIFIED THAT NO OTHER TREATMENT WAS AVAILABLE. THE SITE DOES NOT PERFORM ATHERECTOMY; THEREFORE, THE PROCEDURE WAS CANCELLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251190 ↗

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.