Indigo System LITNGFHT80H1-DRecalls & reported problems
Penumbra, Inc. · CAT16 HTORQ 80cm, Select + 100cm H1 Tip, Lightning Flash 2.0 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 00815948029897), received between Dec 31, 2025 and Dec 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 31, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE RETRACTING THE FLASH CATHETER AFTER COMPLETING THE FINAL PASS, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE DISTAL END OF THE FLASH CATHETER FRACTURED IN THE PULMONARY ARTERY. THE FLASH CATHETER FRACTURE WAS NOTICED UNDER FLUOROSCOPY. THE PROXIMAL PORTION OF THE FLASH CATHETER WAS SUCCESSFULLY REMOVED. THE PHYSICIAN USED A NON-PENUMBRA SHEATH (24F) AND A NON-PENUMBRA SNARE DEVICE TO RETRIEVE THE FRACTURED SEGMENT OF THE FLASH CATHETER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936035 ↗
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- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.