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AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating 2237-40100Recalls & 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132022822), received between Jan 21, 2021 and Jan 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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

  • Material Rupture1

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.

  • MalfunctionJan 21, 2021Material Rupture; Material Rupture

    THE ANGIOSCULPT DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED MID SFA. DURING INFLATION AT 8 ATM, A PINHOLE LEAK WAS DETECTED SINCE CONTRAST COULD BE SEEN ON THE ANGIO. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11211150 ↗

Other Catheter, Percutaneous, Cutting/Scoring devices

All Catheter, Percutaneous, Cutting/Scoring devices →

Sources and updates

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