Indigo SystemRecalls & reported problems across all models

We found 64 models of Indigo System by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 1,873 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2015 and May 27, 2026 — classified as 30 deaths, 143 injuries, 1,700 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (532 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Indigo System problems

Indigo System models

64 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Indigo System CAT6

  CATHETER, EMBOLECTOMY
  2 deaths408 reports
• Indigo System CATRXKIT

  Catheter, Embolectomy
  1 death339 reports
• Indigo System CAT6KIT-A

  Catheter, Embolectomy
  109 reports
• Indigo System LITNG12HTORQ115-A

  Peripheral Mechanical Thrombectomy With Aspiration
  4 deaths105 reports
• Indigo System LITNG7XTORQ130-A

  Peripheral mechanical thrombectomy with aspiration
  100 reports
• Indigo System CAT8XTORQ115

  CATHETER, EMBOLECTOMY
  2 deaths98 reports
• Indigo System LITNG12XTORQ100-A

  Peripheral Mechanical Thrombectomy With Aspiration
  1 death80 reports
• Indigo System SEP8-A

  Catheter, Embolectomy
  2 deaths63 reports
• Indigo System SEP8

  CATHETER, EMBOLECTOMY
  58 reports
• Indigo System SEP6

  CATHETER, EMBOLECTOMY
  57 reports
• Indigo System LITNG12HTORQ100-A

  Peripheral Mechanical Thrombectomy With Aspiration
  1 death46 reports
• Indigo System LITNGBT7TQ130-A

  Peripheral Mechanical Thrombectomy With Aspiration
  46 reports
• Indigo System CAT3-A

  CATHETER, EMBOLECTOMY
  41 reports
• Indigo System CAT8TORQ85

  CATHETER, EMBOLECTOMY
  36 reports
• Indigo System CAT5-A

  CATHETER, EMBOLECTOMY
  26 reports
• Indigo System CAT7DKIT-A

  Peripheral Mechanical Thrombectomy With Aspiration
  20 reports
• Indigo System LITNG8XTORQ115-A

  Peripheral Mechanical Thrombectomy With Aspiration
  17 reports
• Indigo System SEP8-B

  Peripheral mechanical thrombectomy with aspiration
  17 reports
• Indigo System SEP5-A

  CATHETER, EMBOLECTOMY
  16 reports
• Indigo System CAT8STR85

  CATHETER, EMBOLECTOMY
  11 reports
• Indigo System CAT8XTORQ115KIT-A

  Catheter, Embolectomy
  11 reports
• Indigo System LITNGFHT115BER-A

  Peripheral Mechanical Thrombectomy With Aspiration
  4 deaths11 reports
• Indigo System IST3-A

  CATHETER, EMBOLECTOMY
  10 reports
• Indigo System CAT8XTORQ115KIT-S

  Peripheral Mechanical Thrombectomy With Aspiration
  10 reports
• Indigo System CAT8XTORQ115KIT-B

  Peripheral Mechanical Thrombectomy With Aspiration
  9 reports
• Indigo System CAT3

  CATHETER, EMBOLECTOMY
  8 reports
• Indigo System SEP12-A

  Peripheral Mechanical Thrombectomy With Aspiration
  3 deaths8 reports
• Indigo System LITNG8XTORQ115-S

  Peripheral Mechanical Thrombectomy With Aspiration
  7 reports
• Indigo System LITNG12HTORQ115

  Peripheral Mechanical Thrombectomy With Aspiration
  1 death6 reports
• Indigo System SEP7D-A

  Peripheral Mechanical Thrombectomy With Aspiration
  6 reports
• Indigo System LITNGFHT100H1-D

  Peripheral Mechanical Thrombectomy With Aspiration
  1 death6 reports
• Indigo System CAT5

  CATHETER, EMBOLECTOMY
  5 reports
• Indigo System SEP3-A

  CATHETER, EMBOLECTOMY
  5 reports
• Indigo System CAT8TORQ85KIT-A

  Catheter, Embolectomy
  5 reports
• Indigo System CAT8TORQ85KIT-B

  Peripheral Mechanical Thrombectomy With Aspiration
  5 reports
• Indigo System SEP3

  CATHETER, EMBOLECTOMY
  4 reports
• Indigo System CAT8XTORQ115-A

  Peripheral Mechanical Thrombectomy With Aspiration
  4 reports
• Indigo System SEP7-A

  Peripheral Mechanical Thrombectomy With Aspiration
  4 reports
• Indigo System LITNGFHT80BER-A

  Peripheral Mechanical Thrombectomy With Aspiration
  2 deaths4 reports
• Indigo System LITNGFHT100BER-C

  Peripheral Mechanical Thrombectomy With Aspiration
  1 death4 reports
• Indigo System LITNGFXT100H1-D

  Peripheral Mechanical Thrombectomy With Aspiration
  1 death4 reports
• Indigo System LITNGBT6XTX-A

  Peripheral Mechanical Thrombectomy With Aspiration
  3 reports
• Indigo System SEP5

  CATHETER, EMBOLECTOMY
  3 reports
• Indigo System CATRXKIT160

  Catheter, Embolectomy
  3 reports
• Indigo System CAT3KIT-A

  Catheter, Embolectomy
  3 reports
• Indigo System LITNGFHT100BER-A

  Peripheral Mechanical Thrombectomy With Aspiration
  2 deaths3 reports
• Indigo System LITNGFHT115BER-C

  Peripheral Mechanical Thrombectomy With Aspiration
  1 death3 reports
• Indigo System LITNGBT6XTX150-A

  Peripheral Mechanical Thrombectomy With Aspiration
  2 reports
• Indigo System SEPC4

  Catheter, Embolectomy
  2 reports
• Indigo System CAT8STR85KIT-A

  Catheter, Embolectomy
  2 reports
• Indigo System SEP12

  Peripheral Mechanical Thrombectomy With Aspiration
  2 reports
• Indigo System CAT7XTORQ130KIT-A

  Peripheral Mechanical Thrombectomy With Aspiration
  2 reports
• Indigo System CAT8TORQ85KIT-S

  Peripheral Mechanical Thrombectomy With Aspiration
  2 reports
• Indigo System LITNG12HTORQ100

  Peripheral Mechanical Thrombectomy With Aspiration
  2 reports
• Indigo System LITNG12XTORQ100

  Peripheral Mechanical Thrombectomy With Aspiration
  2 reports
• Indigo System LITNGFXT100H1-A

  Peripheral Mechanical Thrombectomy With Aspiration
  2 reports
• Indigo System LITNGFB12HT100-A

  Peripheral Mechanical Thrombectomy With Aspiration
  1 report
• Indigo System IST2

  CATHETER, EMBOLECTOMY
  1 report
• Indigo System CAT5KIT-A

  Catheter, Embolectomy
  1 report
• Indigo System CAT8XTORQ115-R

  CATHETER, EMBOLECTOMY
  1 report
• Indigo System CAT8STR85-A

  Peripheral Mechanical Thrombectomy With Aspiration
  1 report
• Indigo System LITNG12XTORQ115-A

  Peripheral Mechanical Thrombectomy With Aspiration
  1 report
• Indigo System LITNGFHT115H1-D

  Peripheral Mechanical Thrombectomy With Aspiration
  1 death1 report
• Indigo System LITNGFHT80H1-D

  Peripheral Mechanical Thrombectomy With Aspiration
  1 report

Recent Indigo System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BRACHIAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH (7F). THE PHYSICIAN PERFORMED NINE PASSES USING THE CAT7. AFTER COMPLETION OF THE THROMBECTOMY PROCEDURE, THE PHYSICIAN REMOVED THE CAT7 TO DELIVER A NON-PENUMBRA STENT TO THE TARGET LOCATION. AT THIS TIME, THE PHYSICIAN WAS UNAWARE THAT THE CAT7 FRACTURED, LEAVING A FRAGMENT WITHIN THE VESSEL. WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT, THE VESSEL WAS FOUND TO BE OBSTRUCTED. IT WAS NOTED THAT THE FRACTURED CAT7 FRAGMENT WAS LODGED IN THE SHARP CURVE OF THE ARTERIOVENOUS (AV) FISTULA. A NON-PENUMBRA BALLOON DEVICE (2.5 X 40MM) WAS USED TO SUCCESSFULLY REMOVE THE CAT7 FRAGMENT. ALL CAT7 FRAGMENTS WERE FULLY RETRIEVED FROM THE PATIENT. THE STENT WAS THEN PLACED IN THE AV FISTULA, AND THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299844 ↗
• MalfunctionMay 15, 2026Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN A STENT PREVIOUSLY PLACED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. THE PHYSICIAN ADVANCED THE CAT8 THROUGH THE STENT AND INITIATED ASPIRATION. AFTER FOUR PASSES, WHILE RETRACTING THE CAT8, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MID-SECTION OF THE STENT. UNDER FLUOROSCOPY, THE MARKERBAND WAS OBSERVED TO HAVE BECOME DISLODGED AND REMAINED WITHIN THE STENT. A SNARE WAS ADVANCED THROUGH THE SHEATH, AND THE DETACHED MARKERBAND WAS SUCCESSFULLY RETRIEVED FROM THE STENT. THE PROCEDURE WAS COMPLETED USING A NEW CAT6 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25192259 ↗
• 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 ↗
• MalfunctionApr 24, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES TO PLACE A FEMORO-POPLITEAL BYPASS GRAFT USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS WITH THE CATRX. WHILE ASPIRATING AND RETRACTING THE CATRX, THE CATRX FRACTURED MID-SHAFT WITHIN THE SHEATH. THE PHYSICIAN ATTEMPTED TO REMOVE THE FRACTURED SEGMENT FROM THE SHEATH WITH A SNARE DEVICE BUT WAS UNSUCCESSFUL. A BALLOON CATHETER WAS USED TO PIN THE FRACTURED SEGMENT OF THE CATRX TO THE SHEATH AND THE SHEATH CONTAINING THE FRACTURED SEGMENT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW SHEATH AND LYSIS INFUSION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987933 ↗
• MalfunctionApr 23, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), AND A NON-PENUMBRA SHEATH. THE SHEATH WAS ADVANCED UP AND OVER THE BIFURCATION TO THE TARGET LOCATION AND THROMBECTOMY WAS PERFORMED USING THE CAT7. UPON TORQUING THE CAT7, THE PHYSICIAN OBSERVED THAT THE DISTAL END OF THE CAT7 WAS NOT ROTATING UNDER FLUOROSCOPY. THE SHEATH CONTAINING THE FRACTURED PORTION OF THE CAT7 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965967 ↗
• MalfunctionApr 11, 2026Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN A CORONARY ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A GUIDEWIRE. DURING ADVANCEMENT OF THE CATRX OVER THE GUIDEWIRE AND INTO THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE CATRX BECAME STUCK ON THE GUIDEWIRE. WHILE RETRACTING THE CATRX AGAINST RESISTANCE IN ORDER TO CLEAN THE GUIDEWIRE, THE CATRX FRACTURED AT THE PROXIMAL END OF THE GUIDEWIRE LUMEN. IT WAS NOTED THAT ALL PORTIONS OF THE CATRX WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849082 ↗
• MalfunctionApr 11, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA IN THE ARM USING AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D) AND A NON-PENUMBRA SHEATH. THE CAT7D WAS ADVANCED TO THE TARGET LOCATION. UPON INITIATION OF ASPIRATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE CAT7D HAD FRACTURED. THE PHYSICIAN ELECTED TO REMOVE THE CAT7D. DURING WITHDRAWAL THROUGH THE SHEATH, THE CAT7D SEPARATED INTO TWO PIECES OUTSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE ACCESS SITE WITHOUT THE NEED FOR A SNARE. THE PROCEDURE WAS ABORTED AT THAT POINT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO A DIFFERENT OPERATING ROOM; HOWEVER, THIS WAS STATED TO BE UNRELATED TO THE CAT7D FRACTURE. THE PHYSICIAN ELECTED TO PROCEED USING A DIFFERENT TREATMENT APPROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848757 ↗
• MalfunctionApr 1, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, A GUIDE CATHETER (6F), AND A GUIDEWIRE. TWO PASSES WERE COMPLETED USING THE CATRX. THE CATRX WAS THEN REMOVED FOR FLUSHING. UPON REMOVAL, THE CATRX FRACTURED. THE GUIDE CATHETER CONTAINING THE FRACTURED CATRX SEGMENT WAS REMOVED. IT WAS REPORTED THAT NO PORTION OF THE CATRX WAS LEFT IN THE PATIENT. THE PROCEDURE ENDED AT THIS POINT AND THE PATIENT WAS ADMINISTERED TISSUE PLASMINOGEN ACTIVATOR (TPA). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758657 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AND AN ELEMENT VASCULAR ACCESS SHEATH (ELEMENT SHEATH). IT WAS REPORTED THAT DURING THE PROCEDURE, THE HEMOLOCK VALVE SYSTEM WAS LEAKING; HOWEVER, THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SAME ELEMENT SHEATH. ON 24-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL TEAM THAT POST-PROCEDURE, THERE WAS ACCESS SITE BLEEDING AND AN ECCHYMOSIS. TWO-DAYS POST PROCEDURE, THE HEMOGLOBIN DROPPED TO 7.8 G/DL. ONE UNIT OF PACKED RED BLOOD CELLS (PRBCS) WAS GIVEN. THE SITE REMAINED SOFT WITHOUT A HEMATOMA. ACUTE BLOOD LOSS ANEMIA WAS DETERMINED BY THE INDEPENDENT MEDICAL REVIEWER (IMR) TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT IS CONSIDERED RESOLVED.

  Patient problems: Anemia

  MAUDE report 24678799 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A CANISTER, AND A PENUMBRA ENGINE (ENGINE). ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT HAD RIGHT FOOT PAIN AND A RIGHT FOOT ISCHEMIC ULCER. IT WAS NOTED THAT THERE WAS A DISSECTION TO THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY (PROXIMAL) THAT REQUIRED A STENT PLACEMENT. THE PHYSICIAN STATED THAT HE DID NOT SEE THE DISSECTION ON THE POST-TREATMENT ANGIOGRAPHY ON (B)(6) 2025 BUT CANNOT SAY WITH CERTAINTY IF THE DISSECTION IS RELATED. ARTERIAL DISSECTION WAS DETERMINED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM (CAT7) AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT IS ONGOING.

  Patient problems: Vascular Dissection

  MAUDE report 24674978 ↗
• MalfunctionMar 18, 2026

  WHILE PRIMING THE THROMBECTOMY DEVICE ON THE TABLE WE NOTICED THE DEVICES ELECTRONICS WAS DEFECTIVE. WE TRIED A FEW TIMES WITH THE SUPPORT OF THE REP FORM PENUMBRA TO TROUBLE SHOOT THE ERROR BUT NO LUCK. ITEM WAS NEVER USED ON PATIENTS. ITEM REMOVED FROM FIELD AND NEW PRODUCT OPENED ON FIELD THAT WORK WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626093 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERIES AND RIGHT VENTRICLE (RV) USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN REMOVED THROMBUS FROM THE TARGET VESSELS. HOWEVER, IT WAS REPORTED RESIDUAL CLOT REMAINED IN THE RV. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. FOLLOWING THE PROCEDURE, THE PATIENT RECEIVED A 10-HOUR INFUSION OF INTRA-ARTERIAL TPA ALTEPLASE. ON (B)(6) 2025, ONE DAY POST PROCEDURE, THE PATIENT¿S VITAL SIGNS WERE STABLE, WITH A HEART RATE OF 80 BEATS PER MINUTE, A RESPIRATORY RATE OF 18 BREATHS PER MINUTE, AND AN OXYGEN SATURATION OF 99%. ON (B)(6) 2025, TWO DAYS POST PROCEDURE, THE PATIENT REPORTED RECURRENT DYSPNEA. AT THAT TIME, THE HEART RATE HAD INCREASED TO 120 BEATS PER MINUTE, THE RESPIRATORY RATE TO 36 BREATHS PER MINUTE, AND THE OXYGEN SATURATION HAD DECREASED TO 80%. IT WAS REPORTED THAT THERE WAS THROMBUS MIGRATION FROM THE RV TO THE PULMONARY ARTERY. THE PATIENT WAS GIVEN INTRAVENOUS (IV) INFUSION (NOREPINEPHRINE & DOBUTAMINE) AND UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT THE MIGRATED THROMBU

  Patient problems: Thromboembolism

  MAUDE report 24614503 ↗
• MalfunctionMar 16, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM (PE) USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, AFTER COMPLETING TWO PASSES IN THE TARGET LOCATION USING THE SEP6 AND THE CAT8, THE PHYSICIAN REPORTED THAT THE SEP6 FELT DIFFERENT AND WAS NOT BREAKING APART THE THROMBUS AS EFFECTIVELY. AFTER REMOVING THE SEP6, THE BULB WAS FOUND FRACTURED. THE PHYSICIAN PERFORMED A CLINICAL ASSESSMENT AND A CONTRAST INJECTION UNDER FLUOROSCOPY AND WAS UNABLE TO LOCATE THE BULB OF THE SEP6 WITHIN THE PULMONARY VASCULATURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE PATIENT REMAINED STABLE POST-PROCEDURE. IT WAS ALSO REPORTED THAT THE BULB OF THE SEP6 WAS NOT VISIBLY IDENTIFIED IN THE PENUMBRA ENGINE CANISTER (CANISTER) OR THE CAT8. THE PROCEDURE WAS COMPLETED USING THE SAME CAT8.

  Patient problems: Insufficient Information

  MAUDE report 24612930 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT MIXED ACUTE, SUBACUTE, CHRONIC PULMONARY EMBOLISM (PE) ON (B)(6) 2025 USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A NEURON SELECT CATHETER 6F (6F SELECT), AN INDIGO SYSTEM SEPARATOR 12 ((B)(6)), A PENUMBRA ENGINE (ENGINE), AND A GUIDEWIRE. IN THE IMMEDIATE POSTOPERATIVE PERIOD, THE PATIENT PRESENTED WITH RESPIRATORY DECOMPENSATION AND MASSIVE HEMOPTYSIS REQUIRING OROTRACHEAL INTUBATION AND MECHANICAL VENTILATION. IT WAS REPORTED THIS WAS LIKELY DUE TO A REPERFUSION INJURY. THE PATIENT WAS REPORTED TO BE HEMODYNAMICALLY STABLE WITHOUT VASOPRESSOR USE AND WAS PLACED ON FIO2 100% WITH O2 SATS OF 94% AND TRANSFERRED BACK TO THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2025, THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS EXTUBATED WITH GRADUAL INCREASE OF OXYGEN REQUIREMENTS. THE PATIENT WAS ALSO STARTED ON A BLOOD THINNER (CLEXANE, ENOXAPARIN SODIUM). ON (B)(6) 2025, THE PATIENT WAS TRANSITIONED TO ANOTHER BLOOD THINNER (MAREVAN, WARFARIN SODIUM) WHILE CONTINUING CLEXANE AS A BRIDGE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025 WITH SLIGHT DYSPNEA. THE PATIENT MISSED THE 90-DAY FOLLOW-UP APPOINTMENT. THE R

  Patient problems: Reperfusion Injury

  MAUDE report 24607529 ↗
• InjuryMar 16, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. THE PHYSICIAN COMPLETED ONE PASS USING THE CATRX. AFTER THE COMPLETION OF THE PROCEDURE, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE CATRX FRACTURED AT THE DISTAL END IN THE COMMON FEMORAL ARTERY (CFA). THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND A CUTDOWN SURGERY WAS PERFORMED TO REMOVE THE FRACTURED CATRX. NO PORTION OF THE CATRX WAS LEFT IN THE PATIENT'S BODY. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED THE NEXT DAY AND WAS DOING FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24602356 ↗

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