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Indigo System IST2Recalls & reported problems

Penumbra, Inc. · Indigo Aspiration Tubing · Class 2

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 00814548013336), received between Nov 20, 2015 and Nov 20, 2015 — classified as 1 malfunction.

The most frequently reported specific device problem is “Aspiration Issue” (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

  • Aspiration Issue1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionNov 20, 2015Aspiration Issue

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, WHILE PRIMING THE INDIGO SYSTEM ASPIRATION TUBING (TUBING), THE HOSPITAL STAFF NOTICED THAT THE TUBING WOULD NOT ASPIRATE AND DID NOT USE THE TUBING IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW TUBING.

    Patient problems: No Patient Involvement

    MAUDE report 5241253 ↗

Other CATHETER, EMBOLECTOMY devices

All CATHETER, EMBOLECTOMY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.