IndigoRecalls & reported problems across all models

We found 6 models of Indigo by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2017 and Nov 23, 2021 — classified as 3 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (23 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 problems

Indigo models

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

• Indigo CATD

  Catheter, embolectomy
  30 reports
• Indigo IAPS3

  Peripheral mechanical thrombectomy with aspiration
  9 reports
• Indigo CATD-C

  Catheter, Embolectomy
  6 reports
• Indigo SEPD

  Catheter, Embolectomy
  4 reports
• Indigo CATD-S

  Peripheral Mechanical Thrombectomy With Aspiration
  2 reports
• Indigo CATD-D

  Peripheral Mechanical Thrombectomy With Aspiration
  1 report

Recent Indigo adverse event reports

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

• MalfunctionNov 23, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A FISTULA GRAFT USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY TWO TO THREE PASSES IN THE TARGET VESSEL USING THE CATD. WHILE ADVANCING THE CATD THROUGH CLOT IN THE PATIENT DURING THE NEXT PASS, THE PHYSICIAN KINKED THE CATD AT THE DISTAL END. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD 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 12863490 ↗
• MalfunctionNov 12, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN, ILIAC VEIN, AND INFERIOR VENA CAVA (IVC) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), AND LIGHTNING ASPIRATION TUBING (LIGHTNING). DURING THE PROCEDURE, THE ENGINE WAS UNABLE TO OBTAIN VACUUM AND NONE OF THE INDICATOR LIGHTS WOULD ILLUMINATE ON THE ENGINE USING THE CANISTER. IT WAS ALSO REPORTED THAT THE INDICATOR LIGHT ON THE LIGHTNING UNIT BEGAN FLASHING RED. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER WITH THE SAME ENGINE AND LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801719 ↗
• MalfunctionJul 19, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FISTULA UPPER EXTREMITY USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CATD WOULD NOT ADVANCE THROUGH THE VALVE OF THE SHEATH, AND THE TIP OF THE CATD BENT. IT WAS REPORTED AN INTRODUCER HAD BEEN USED. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD AND NEW NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194237 ↗
• MalfunctionJul 2, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY USING A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), AND ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE HOSPITAL STAFF PLACED THE CANISTER ONTO THE ENGINE AND NOTICED THAT ONLY TWO OF THE FOUR INDICATOR LIGHTS AROUND THE POWER BUTTON ON THE ENGINE WERE ILLUMINATED. IT WAS REPORTED THAT AN ATTEMPT TO TROUBLESHOOT WAS MADE BY REMOVING THE CANISTER AND REATTACHING THE TUBING; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111562 ↗
• MalfunctionJun 26, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT POPLITEAL ARTERY USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN REALIZED THAT THE CANISTER LOST ITS SUCTION; THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS REPORTED THAT THE LID OF THE FIRST CANISTER WAS NOT THREADED PROPERLY AND WHEN TIGHTENED APPROPRIATELY, IT WORKED. HOWEVER, THE SECOND CANISTER WAS ALREADY BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072368 ↗
• MalfunctionJun 9, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CORONARY ARTERY USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN NOTICED NONE OF THE INDICATOR LIGHTS ON THE ENGINE WOULD ILLUMINATE AND THE ENGINE WAS NOT GENERATING ASPIRATION. THE GROMMETS NEAR THE CANISTERS WERE REMOVED IN AN ATTEMPT TO TROUBLESHOOT; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS ALSO REPORTED THAT THE VACUUM RELEASE LEVER WAS DEPRESSED. THEREFORE, ENGINE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A MANUAL ASPIRATION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971312 ↗
• MalfunctionMay 3, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (AVF) USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION USING THE CATD. DURING THE NEXT PASS, THE PHYSICIAN KINKED THE DISTAL TIP OF THE CATD TWICE WHILE ADVANCING THE CATD IN THE AV FISTULA AT THE ANASTOMOSIS FROM THE VENOUS TO ARTERIAL. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD 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 11765400 ↗
• MalfunctionMar 18, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AN ASPIRATION TUBING (TUBING), A PENUMBRA ENGINE (ENGINE), AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE INDICATOR LIGHT ON THE LIGHTNING UNIT TURNED SOLID RED AFTER TURNING THE FLOW SWITCH TO THE ON POSITION. TO TROUBLESHOOT, THE PHYSICIAN UNPLUGGED AND PLUGGED BACK IN THE CORD FROM THE LIGHTNING TO THE USB PORT ON THE ENGINE, FLUSHED THE CAT8 AND TUBING, AS WELL AS MAKING SURE THAT THE CANISTER WAS SEATED PROPERLY ON THE ENGINE. HOWEVER, THE LIGHTNING UNIT REMAINED SOLID RED AND NONE OF THE FOUR INDICATOR LIGHTS ON THE ENGINE ILLUMINATED. SUBSEQUENTLY, THE LIGHTNING WAS REMOVED AND EXCHANGED FOR A NEW LIGHTNING, BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN THEN EXCHANGED THE ENGINE FOR A SECOND ENGINE, BUT THE LIGHTNING UNIT REMAINED SOLID RED AND NONE OF THE FOUR INDICATOR LIGHTS ON THE ENGINE ILLUMINATED. THEREFORE, THE PHYSICIAN REMOVED THE CANISTER. IT WAS ALSO REPORTED THAT THE FIRST ENGINE WAS TESTED WITH THE NEW CANISTER AND IT WAS NOTED THAT THE ENGINE WAS ABLE TO ACHIEVE FULL ASPIRATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510461 ↗
• MalfunctionJan 29, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE INSERTING THE CATD INTO THE SHEATH, THE PHYSICIAN OVALIZED THE DISTAL TIP OF THE CATD. THEREFORE, THE CATD AND SHEATH WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD AND A NEW NON-PENUMBRA SHEATH. 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 11254766 ↗
• MalfunctionJan 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT POPLITEAL ARTERY USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE HOSPITAL STAFF SETUP THE CANISTER AND ENGINE. AFTER TURNING ON THE ENGINE, IT WAS NOTICED THAT THE VACUUM PRESSURE WAS LOW AND THE INDICATOR LIGHTS ON THE ENGINE DID NOT ILLUMINATE. THEREFORE, THE ENGINE AND CANISTER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER THROMBECTOMY SYSTEM. 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 11191335 ↗
• MalfunctionOct 20, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUDED ARTERIOVENOUS (AV) FISTULA USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, A PINNACLE SHEATH WAS PLACED IN THE DIALYSIS FISTULA. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AFTER ADVANCING THE CATD A FEW CENTIMETERS THROUGH THE SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE CATD AND NOTICED THE DISTAL TIP TO BE OVALIZED. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THE SHEATH TO BE KINKED UNDER FLUOROSCOPY AND THE CATD BECAME DAMAGED UPON ADVANCING THROUGH THE KINKED SECTION OF THE SHEATH AND, THEREFORE, THE SHEATH WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD AND SHEATH. 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 10708694 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS (AV) FISTULA GRAFT USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD), A GUIDEWIRE AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATD OVER THE GUIDEWIRE THROUGH THE SHEATH FROM THE BRACHIAL ARTERY TO THE AV GRAFT AND ATTEMPTED TO PERFORM ASPIRATION USING THE CATD. HOWEVER, AFTER FIVE MINUTES, THE CATD WAS NOT ASPIRATING, AND THE PHYSICIAN REALIZED THE DISTAL END OF THE CATD WAS KINKED. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD 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 10525737 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD), INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CATD THROUGH THE SHEATH, THE MID-SHAFT OF THE CATD KINKED. SUBSEQUENTLY, THE CATD WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING THE CATRX AND THE SHEATH. WHILE ADVANCING THE CATRX THROUGH THE SHEATH, THE PROXIMAL END OF THE CATRX KINKED. THEREFORE, THE CATRX WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522115 ↗
• MalfunctionAug 21, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INFERIOR VENA CAVA (IVC) USING A PENUMBRA ENGINE CANISTER (CANISTER), A PENUMBRA ENGINE (ENGINE), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A SHEATH, AND GUIDEWIRE. DURING THE PROCEDURE, THE CAT8 WAS ADVANCED OVER THE GUIDEWIRE AND THROUGH A SHEATH. NEXT, THE ENGINE WITH THE CANISTER WAS CONNECTED TO THE CAT8 AND THE ENGINE WAS POWERED ON. HOWEVER, NOT ALL FOUR OF THE INDICATOR LIGHTS ON THE ENGINE ILLUMINATED AND MAXIMUM VACUUM PRESSURE WAS NOT ACHIEVED. TO TROUBLESHOOT, THE CANISTER WAS REMOVED AND PLACED BACK INTO THE ENGINE THREE TIMES. IN ADDITION, THE ENGINE WAS POWERED OFF AND POWERED ON THREE TIMES; HOWEVER, THE ISSUE WAS NOT RESOLVED. THEREFORE, THE ENGINE WAS DISCONNECTED AND REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE USING ANOTHER ENGINE AND THE SAME CANISTER, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SECOND ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437135 ↗
• MalfunctionJul 30, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT AND LEFT PULMONARY ARTERY USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, WHILE ATTEMPTING TO START ASPIRATION, THE PHYSICIAN NOTICED NONE OF THE LIGHTS ON THE ENGINE WOULD NOT ILLUMINATE. THE CANISTER WAS REPOSITIONED MULTIPLE TIMES ON THE ENGINE; HOWEVER, THE LIGHTS ON THE ENGINE WOULD NOT ILLUMINATE. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347545 ↗

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