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Indigo CATD-SRecalls & reported problems

Penumbra, Inc. · Aspiration Catheter D Kit · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948022348), received between Jul 19, 2021 and Nov 23, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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

  • Material Deformation2
  • Failure to Advance1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 23, 2021Material Deformation; Material Deformation

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A FISTULA GRAFT USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY TWO TO THREE PASSES IN THE TARGET VESSEL USING THE CATD. WHILE ADVANCING THE CATD THROUGH CLOT IN THE PATIENT DURING THE NEXT PASS, THE PHYSICIAN KINKED THE CATD AT THE DISTAL END. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12863490 ↗
  • MalfunctionJul 19, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FISTULA UPPER EXTREMITY USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CATD WOULD NOT ADVANCE THROUGH THE VALVE OF THE SHEATH, AND THE TIP OF THE CATD BENT. IT WAS REPORTED AN INTRODUCER HAD BEEN USED. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD AND NEW NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12194237 ↗

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