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AngioSculpt® 2290-50100Recalls & reported problems

Spectranetics Corporation · AngioSculpt® PTA Scoring Balloon Catheter · Class 2

Data updated Oct 13, 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 00813132021597), received between Apr 20, 2018 and Apr 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component1
  • Retraction Problem1

Patient problems

  • Atherosclerosis1
  • Peripheral Vascular Disease1

Recent adverse event reports

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

  • InjuryApr 20, 2018Detachment Of Device Component; Retraction Problem; Detachment Of Device Component; Retraction Problem

    Patient problems: Atherosclerosis; Peripheral Vascular Disease

    MAUDE report 7449160 ↗

Other Catheter, Percutaneous, Cutting/Scoring devices

All Catheter, Percutaneous, Cutting/Scoring devices →

Sources and updates

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