Indigo System CAT7XTORQ130KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948021648), received between Feb 17, 2021 and Mar 26, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE POPLITEAL USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT HAD TORTUOUS ILIACS AND BIFURCATIONS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A FEW PASSES USING THE CAT7. WHILE WITHDRAWING THE CAT7 FROM THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE. AFTER THE CAT7 WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTICED THE CAT7 HAD KINKED MID-SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AT THIS POINT AND NO ADDITIONAL PASSES WERE REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574916 ↗
• MalfunctionFeb 17, 2021Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE OF AN OCCLUDED STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE TIP OF THE CAT7 KINKED WHEN ADVANCED OUT OF THE SHEATH WITHOUT A GUIDEWIRE. IT WAS REPORTED THAT THIS MAY HAVE BEEN DUE TO AN INTERACTION WITH THE STENT. AN 0.035" GUIDE WIRE WAS THEN ADVANCED THROUGH THE CAT7 TO STRAIGHTEN OUT THE TIP. THE GUIDEWIRE WAS THEN REMOVED. THE PHYSICIAN THEN TORQUED THE CAT7 ONE FULL ROTATION AND NOTICED THE DISTAL TIP WAS NOT RESPONDING. THE CATHETER HAD FRACTURED PROXIMAL TO THE VASCULAR SHEATH VALVE, OUTSIDE OF THE PATIENT. SUBSEQUENTLY, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND THE SAME 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 11337835 ↗