Indigo System Lightning Flash LITNGFXT100H1-FRecalls & reported problems
Penumbra, Inc. · Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 100cm XTORQ Tip, Select+ 120cm H1 Tip · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810169722541), received between Mar 13, 2026 and Mar 13, 2026 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT AND RIGHT LUNGS USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN ELEMENT VASCULAR ACCESS SHEATH (ELEMENT), A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, GUIDEWIRE, AND A MICRO ACCESS KIT. AFTER SUCCESSFULLY TREATING THE RIGHT LOBE USING THE FLASH CATHETER, THE GUIDEWIRE AND THE FLASH CATHETER WERE ADVANCED INTO THE LEFT PULMONARY ARTERY. TWO SUCCESSFUL PASSES WERE COMPLETED USING THE FLASH CATHETER IN THE LEFT LOWER LOBE. THE GUIDEWIRE WAS FIRST ADVANCED INTO THE SUB-SEGMENTAL BRANCH OF THE LOWER LEFT LOBE AND THE FLASH CATHETER WAS THEN ADVANCED OVER THE GUIDEWIRE TOWARD THE BRANCH. THE GUIDEWIRE WAS RETRACTED INTO THE FLASH CATHETER TO PERFORM A CONTRAST INJECTION. IT WAS REPORTED THAT THE PATIENT STARTED TO COUGH UP BLOOD. THE CONTRAST INJECTION REVEALED CONTRAST STAINING ON THE SUB-SEGMENTAL BRANCH OF THE LOWER LEFT LOBE. THE FLASH CATHETER WAS REMOVED. A NON-PENUMBRA BALLOON DEVICE (6MM) WAS USED TO STOP THE BLEED UNDER FLUOROSCOPY. THE PHYSICIAN REPORTED IT IS UNCLEAR IF THE GUIDEWIRE OR THE FLASH CATHETER ATTRIBUTED TO THE VESSEL PERFORATION. THE PATIENT WAS REPORTED TO BE STABLE AND DOING
Patient problems: Perforation of Vessels
MAUDE report 24596291 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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