Indigo System Lightning Flash LITNGFHT100H1-FRecalls & reported problems
Penumbra, Inc. · Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 100cm HTORQ Tip, Select+ 120cm H1 Tip · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810169722534), received between Sep 2, 2026 and Sep 2, 2026 — classified as 1 death.
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.
DeathSep 2, 2026Adverse Event Without Identified Device or Use Problem
The patient underwent a bilateral pulmonary artery mechanical thrombectomy using an Indigo System Flash Aspiration Catheter (Flash Catheter), an angled pigtail catheter, a non-Penumbra 17F sheath, and guidewires. Toward the end of the procedure, following thrombus removal from the large branches, a small amount of thrombus remained in the subsegmental branches. The patient developed dyspnea, tachycardia, and pallor. Angiographic imaging acquired during the procedure demonstrated contrast staining of the cardiac border with contrast extending into the left pleural space consistent with pulmonary vascular injury, and a pleural effusion that developed as the procedure progressed. The effusion was corroborated by chest X-ray. Heparin was reversed with 50 mg of protamine, and balloon tamponade was performed in the left lower segmental pulmonary artery using a balloon device. Following tamponade, repeat angiography demonstrated no further extravasation. The patient's respiratory status continued to deteriorate, and the procedure was terminated for further stabilization.The patient was transferred to the post-anesthesia care unit, where furosemide was administered and BIPAP/respiratory th
Patient problems: Perforation of Vessels
MAUDE report 50573082 ↗
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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