Indigo System IST3-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814548016221), received between Jan 12, 2016 and Jul 18, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Aspiration Issue” (3 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2021Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT AXILLARY ARTERY USING AN INDIGO SYSTEM ASPIRATION TUBING (TUBING) AND AN INDIGO SYSTEM CAT 6 ASPIRATION CATHETER. DURING THE PROCEDURE, THE PHYSICIAN NOTICED A LEAK AT THE FLOW SWITCH OF THE TUBING. THE PHYSICIAN DECIDED TO REMOVE THE FLOW SWITCH AND CONNECT THE TUBING DIRECTLY TO THE CAT6 TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186417 ↗
• MalfunctionNov 21, 2019Complete Blockage; Complete Blockage

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RENAL VEIN USING AN INDIGO SYSTEM ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE TUBING BECAME CLOGGED AND THE PHYSICIAN WAS UNABLE TO UNCLOG IT; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW A TUBING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9354662 ↗
• MalfunctionApr 17, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE SCRUB TECHNOLOGIST INADVERTENTLY DROPPED AN INDIGO SYSTEM ASPIRATION TUBING (TUBING) ON THE FLOOR WHEN THE PACKAGING WAS OPENED. CONSEQUENTLY, THE TUBING BECAME CONTAMINATED. THE TUBING WAS DROPPED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 7437533 ↗
• MalfunctionMar 16, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE INDIGO SYSTEM ASPIRATION TUBING (ASPIRATION TUBING) WAS DROPPED ON THE FLOOR UPON REMOVAL FROM THE PACKAGING. THE ASPIRATION TUBING WAS DROPPED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ASPIRATION TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 7346240 ↗
• MalfunctionNov 9, 2017Complete Blockage; Aspiration Issue; Complete Blockage; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING INDIGO SYSTEM ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE TUBING BECAME CLOGGED AND WAS UNABLE TO BE USED WITH ASPIRATION, EVEN AFTER REMOVING THE FLOW SWITCH TO CLEAN THE TUBING, AND ATTEMPTING TO ASPIRATE THROUGH THE TUBING WITHOUT THE ROTATING HEMOSTASIS VALVE (RHV). THE PHYSICIAN THEREFORE COMPLETED THE PROCEDURE USING A NEW TUBING AND THE SAME INDIGO SYSTEM CAT8 ASPIRATION CATHETER (CAT8). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7016367 ↗
• MalfunctionNov 11, 2016Device Operates Differently Than Expected; Difficult to Open or Close; Device Operates Differently Than Expected; Difficult to Open or Close

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX) AND THE INDIGO SYSTEM ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE PUMP MAX WAS POWERED ON AND THE GREEN POWER BUTTON ILLUMINATED BUT THE PUMP MAX WAS UNABLE TO CREATE VACUUM. IN ADDITION, THE PHYSICIAN NOTICED THAT THE VALVE ON THE TUBING WOULD NOT OPEN. THE TECHNICIAN THEN CHANGED OUT THE TUBING FOR A NEW PENUMBRA SYSTEM ASPIRATION TUBING (NEW TUBING) AND UNPLUGGED THE PUMP MAX SEVERAL TIMES. AFTER ABOUT THREE MINUTES OR SO, THE PUMP MAX WAS ABLE TO PRODUCE VACUUM THROUGH THE NEW TUBING. THEREFORE, THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX AND THE NEW TUBING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6096125 ↗
• MalfunctionJun 23, 2016Contamination; Device Handling Problem; Contamination; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) DEVICES AND AN INDIGO SYSTEM ASPIRATION TUBING (TUBING). DURING PREPARATION FOR THE PROCEDURE, WHILE THE TUBING PACKAGING WAS BEING OPENED, PART OF THE TUBING POPPED OUT AND WAS CONTAMINATED BY A NON-STERILE HAND. THE TUBING WAS CONTAMINATED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. A NEW TUBING WAS THEN OPENED FOR THE PROCEDURE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CAT6 THROUGH ANOTHER MANUFACTURER'S SHEATH, THE PHYSICIAN INADVERTENTLY KINKED THE CAT6. THE KINKED CAT6 WAS THEN REMOVED AND A NEW CAT6 WAS OPENED. THE PHYSICIAN DID NOT REPORT ANY RESISTANCE, FRICTION OR DIFFICULTY WHILE ADVANCING THE FIRST CAT6. HOWEVER, WHILE ATTEMPTING TO ADVANCE THE SECOND CAT6 THROUGH THE SAME SHEATH, THE PHYSICIAN MET RESISTANCE. AT THIS POINT, THE PHYSICIAN SUSPECTED THAT THE SHEATH WAS KINKED AND DECIDED TO DISCONTINUE USE OF THE PENUMBRA DEVICES AND PLACE A LYTIC CATHETER IN THE PATIENT INSTEAD. THE SECOND CAT6 WAS REMOVED AND ANOTHER MANUFACTURER'S LYTIC CATHETER WAS OPENED. THE PHYSICIAN HAD DIFFICULTY PLACING THE CATHETER AND ENCOUNTERED RESISTANCE, BUT UL

  Patient problems: No Patient Involvement

  MAUDE report 5746613 ↗
• MalfunctionApr 8, 2016Aspiration Issue; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A DEEP VEIN THROMBOSIS (DVT) USING THE INDIGO SYSTEM ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, NO ASPIRATION WAS POSSIBLE. THE TUBING WAS REMOVED AND ATTEMPTS TO ASPIRATE SALINE WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING NEW TUBING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5563554 ↗
• MalfunctionFeb 1, 2016Suction Problem; Defective Component; Out-Of-Box Failure; Device Operational Issue; Suction Problem; Defective Component; Out-Of-Box Failure; Device Operational Issue

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE FLOW SWITCH ON THE IST3 INDIGO SYSTEM ASPIRATION TUBING (TUBING) WAS NOT WORKING PROPERLY. THE TUBING WAS CONNECTED TO A PENUMBRA SYSTEM PUMP MAX 110V (PUMP MAX) AND THE PUMP MAX WAS SWITCHED ON; HOWEVER, THERE WAS NO SUCTION AT THE DISTAL TIP. THE DEFECTIVE TUBING WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 5401804 ↗
• MalfunctionJan 12, 2016Aspiration Issue; Device Operational Issue; Aspiration Issue; Device Operational Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION TUBING 3 (TUBING). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE TUBING WAS NOT ASPIRATING EVEN THOUGH THE FLOW SWITCH WAS ON. THE PHYSICIAN SWAPPED OUT THE TUBING FOR A NEW INDIGO SYSTEM ASPIRATION TUBING 2 AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5360696 ↗