Indigo System LITNGBT6XTX150-ARecalls & reported problems
Penumbra, Inc. · CAT6X w/TraX + Lightning Bolt, 150cm · Class 2
All models of Indigo System (64)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00810169722466), received between Jan 23, 2026 and Apr 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
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.
MalfunctionApr 29, 2026Fracture
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE VIA PEDAL ACCESS USING AN INDIGO SYSTEM ASPIRATION CATHETER 6X (CAT6X), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), A TRAX DELIVERY DEVICE (TRAX), AND A NON-PENUMBRA SHEATH. THE CAT6X WAS NOTED TO BE FRACTURED ON THE MIDSHAFT. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. THE CAT6X WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25037621 ↗MalfunctionJan 23, 2026Fracture
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT LOWER EXTREMITY ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6X (CAT6X), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT6X. THE CAT6X WAS REMOVED FROM THE PATIENT ALONG WITH THE GUIDEWIRE. AFTER REMOVAL, THE PHYSICIAN NOTICED THAT THE CAT6X MID-SHAFT WAS FRACTURED. THE CAT6X WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE BY ADMINISTERING TISSUE PLASMINOGEN ACTIVATOR (TPA), AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24173026 ↗
Other Peripheral Mechanical Thrombectomy With Aspiration devices
- Indigo System LITNG12HTORQ115-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration4 deaths105 reports
- Indigo System LITNG7XTORQ130-APenumbra, Inc. · Peripheral mechanical thrombectomy with aspiration100 reports
- 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 LITNGBT7TQ130-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration46 reports
- Indigo System LITNG12HTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death46 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 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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