Indigo System CAT8TORQ85KIT-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948022294), received between Nov 2, 2021 and Jan 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJan 8, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AN INDIGO SYSTEM SEPARATOR 8 (SEP8), A GUIDING SHEATH, A STENT, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 AND SEP8 INTO THE TARGET VESSEL USING THE GUIDING SHEATH AND INITIATED ASPIRATION. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT8 INTO THE GUIDING SHEATH. THE CAT8 WAS THEN TORQUED TO PERFORM ASPIRATION OVER A WIDE AREA. AFTER PULLING ON THE HUB OF THE CAT8 APPROXIMATELY 2-3 CENTIMETERS, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL PART OF THE CAT8 DID NOT MOVE. UNDER FLUOROSCOPY THE PHYSICIAN CHECKED THE ILIAC BIFURCATION AND FOUND THAT THE MID-SHAFT OF THE CAT8 HAD FRACTURED AT THE BIFURCATION. THE PHYSICIAN THEN USED A BALLOON CATHETER TO HOLD THE CAT8 AND SEP8 IN PLACE INSIDE OF THE GUIDING SHEATH TO REMOVE THE DEVICES TOGETHER. THE PHYSICIAN ALSO ATTEMPTED TO INSERT THE GUIDEWIRE FOR ADDITIONAL SUPPORT, BUT THE GUIDEWIRE WOULD NOT ENTER THE FRACTURED SECTION OF THE CAT8. WHILE REMOVING, THE PHYSICIAN CUT ANOTHER SEGMENT OF THE CAT8 USING SCISSORS. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466129 ↗
• MalfunctionNov 2, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES IN THE TARGET VESSEL USING THE CAT8. WHILE TORQUING THE CAT8, THE PHYSICIAN FRACTURED THE CAT8 NEAR THE HUB, AND THE HUB OF THE CAT8 SEPARATED FROM THE CATHETER. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741028 ↗