Indigo System LITNGFB12HT100-ARecalls & reported problems
Penumbra, Inc. · CAT12 100 HTORQ plus Lightning Bolt Aspiration Tubing, no CE · 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 00810169720011), received between Dec 24, 2025 and Dec 24, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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 24, 2025Material Fragmentation; Material Fragmentation
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN IN-STENT THROMBOSIS IN THE FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, AFTER COMPLETING 3 TO 5 PASSES IN THE TARGET LOCATION USING THE CAT12, THE PHYSICIAN RETRACTED THE CAT12 OUT OF THE PATIENT TO PERFORM A VENOGRAM. UPON REMOVAL OF THE CAT12, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE CAT12 WAS DAMAGED. THEREFORE, THE CAT12 AND THE LIGHTNING BOLT WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT12 AND A NEW LIGHTNING BOLT. IT SHOULD BE NOTED THAT THERE WERE NO ALLEGED DEFICIENCY ASSOCIATED WITH THE FIRST LIGHTNING BOLT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23891493 ↗
Other Peripheral Mechanical Thrombectomy With Aspiration devices
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- Indigo System LITNG12XTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death80 reports
- ClotTriever XL Catheter AS-0235Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 recall9 deaths20 reports
- Indigo System LITNG12HTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death46 reports
- Indigo System LITNGBT7TQ130-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration46 reports
- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
- ClotTriever Catheter, 16 mm 40-102Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration11 deaths27 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.