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AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating 2216-20100Recalls & reported problems

The Spectranetics Corporation · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132022891), received between May 3, 2019 and May 3, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Entrapment of Device” (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

  • Entrapment of Device1
  • Failure to Advance1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • InjuryMay 3, 2019Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

    AFTER TWO INFLATION, THE ANGIOSCULPT GOT STUCK ON THE GUIDE WIRE AND COULD NOT BE MOVED TO A DIFFERENT TARGET AREA. THE DEVICE AND GUIDE WIRE WERE REMOVED AS A UNIT WITH NO PATIENT INJURY. THE LESION WAS REWIRED AND COMPLETED WITH ANOTHER BALLOON.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8577847 ↗

Other Catheter, Percutaneous, Cutting/Scoring devices

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Sources and updates

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