Indigo System LITNG12HTORQ100Recalls & reported problems
Penumbra, Inc. · CAT12 100 New HTORQ shape Plus Lightning, CE · Class 2
All models of Indigo System (64)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948022904), received between Nov 27, 2024 and Jan 16, 2025 — classified as 2 injuries.
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 Problem2
Patient problems
- Anemia1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE SEGMENTAL AND SUBSEGMENTAL BRANCHES OF THE PULMONARY ARTERIES USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AND A PENUMBRA ENGINE (ENGINE). THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, AND THE ACCESS SITE DID NOT SHOW SIGNS OF BLEEDING. FORTY-THREE MINUTES POST-PROCEDURE THE PATIENT DEVELOPED ANEMIA, WITH A DROP IN HEMOGLOBIN OF 2 G/DL FROM BASELINE. THE PATIENT WAS ADMINISTRATED ONE UNIT OF PACKED RED BLOOD CELLS (PRBCS). ON (B)(6) 2024, THE PATIENT WAS ADMINISTERED AN ADDITIONAL ONE UNIT OF PRBCS WITH NO COMPLICATIONS RELATED TO THE TRANSFUSION. IT WAS REPORTED THAT THE DRESSING REMAINED DRY AND CLEAN, AND THE PATIENT WAS FASTING FOR A CHEST COMPUTED TOMOGRAPHY (CT) SCAN SCHEDULED FOR THE NEXT DAY. ON (B)(6) 2024, THE PATIENT WAS ADMINISTERED TWO MORE UNITS OF PRBCS WITHOUT ANY ADVERSE BODY REACTION. ON (B)(6) 2024, THE PATIENT REPORTED IMPROVED WELLBEING, MOBILITY AND DECREASE IN INFLAMMATORY PARAMETERS. THE PATIENT WAS CONSIDERED INDEPENDENT AND REQUIRED MINIMAL NURSING CARE. THE EVENT IS CONSIDERED RESOLVED. THE IN
Patient problems: Anemia
MAUDE report 21174272 ↗InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM (PE) AFTER KNEE SURGERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. ON (B)(6) 2024, THE PATIENT¿S HEMOGLOBIN LEVEL WAS 6.9 G/DL AND THE PATIENT WAS BLEEDING FROM THE SURGICAL WOUND. THE PATIENT WAS ADMINISTERED A REDUCED DOSE OF ANTICOAGULATION AND TRANSFUSION OF FOUR UNITS OF BLOOD. ON (B)(6) 2024, AN INFERIOR VENA CAVA (IVC) FILTER WAS IMPLANTED. THE EVENT IS CONSIDERED RESOLVED. THE INDEPENDENT MEDICAL REVIEWER (IMR) ADJUDICATED THE BLEEDING FROM THE SURGICAL WOUND AS A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO SYSTEM ASPIRATION CATHETER 12 AND INDEX PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20797474 ↗
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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