Indigo System LITNG12XTORQ115-ARecalls & reported problems
Penumbra, Inc. · CAT12 115 New XTORQ shape plus Lightning · Class 2
All models of Indigo System (64)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00815948022591), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Circuit Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Circuit Failure1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2020Circuit Failure; Obstruction of Flow; Circuit Failure; Obstruction of Flow
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL AND ILIAC VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THERE WAS AN INITIAL STRONG ASPIRATION WHEN THE PHYSICIAN TURNED THE ENGINE ON. SUBSEQUENTLY, THE LIGHTNING CLOGGED AND THE INDICATOR LIGHT ON THE LIGHTNING UNIT TURNED FROM GREEN TO RED. THEREFORE, THE PHYSICIAN ATTEMPTED TO USE A SYRINGE TO FLUSH THE THROMBUS THROUGH THE LIGHTNING. THE PHYSICIAN WAS ABLE TO FLUSH THE MAJORITY OF THE THROMBUS OUT OF THE LIGHTNING; HOWEVER, THE INDICATOR LIGHT REMAINED RED. NEXT, THE PHYSICIAN UNPLUGGED AND RE-PLUGGED THE LIGHTNING UNIT FROM THE ENGINE A FEW TIMES BUT THE INDICATOR LIGHT REMAINED RED. LASTLY, THE PHYSICIAN POWER CYCLED THE ENGINE AND THE INDICATOR LIGHT REMAINED RED; THEREFORE, THE LIGHTNING WAS REMOVED AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10794415 ↗
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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