Indigo System CAT8XTORQ115-RRecalls & reported problems
Penumbra, Inc. · Ind Asp Cat 8, 115cm-XTORQ · Class 2
All models of Indigo System (64)
Data updated Oct 16, 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 00815948022300), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2023Material Fragmentation; Material Fragmentation
THE PATIENT UNDERWENT A SUCCESSFUL THROMBECTOMY PROCEDURE IN THE LEFT BRACHIAL ARTERY USING AN INDIGO SYSTEM CAT8 ASPIRATION CATHETER (CAT8), A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NON-PENUMBRA SHEATH, A BALLOON DILATATION CATHETER AND A GUIDEWIRE. A FINAL ANGIOGRAM WAS PERFORMED AND IDENTIFIED A METAL PIECE IN THE RADIAL ARTERY. IT IS UNKNOWN WHERE THE METAL PIECE HAD COME FROM. UPON REMOVAL OF THE CAT8, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE CAT8 WAS PEELED OFF. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17386825 ↗
Other CATHETER, EMBOLECTOMY devices
- Indigo System CAT6Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths408 reports
- Indigo System CATRXKITPenumbra, Inc. · Catheter, Embolectomy1 death339 reports
- Fogarty 120804FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall1 death200 reports
- LeMaitre Embolectomy Catheter 1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall161 reports
- FOGARTY 120404FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall61 reports
- Indigo System CAT6KIT-APenumbra, Inc. · Catheter, Embolectomy109 reports
- LeMaitre Embolectomy Catheter e1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy2 recalls4 reports
- Indigo System CAT8XTORQ115Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths98 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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