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AngioSculpt® PTCA Scoring Balloon Catheter 2001-3520Recalls & reported problems

Angioscore Inc. · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M3702001352011), received between Jul 1, 2018 and Jul 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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

Device problems

  • Burst Container or Vessel1

Patient problems

  • Atherosclerosis1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 1, 2018Burst Container or Vessel; Burst Container or Vessel

    Patient problems: Atherosclerosis

    MAUDE report 7653989 ↗

Other Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring devices

All Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring devices →

Sources and updates

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