Indigo System CATRXKIT160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548017587), received between Aug 3, 2017 and Sep 21, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Aspiration Issue” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2017Kinked; Aspiration Issue; Kinked; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CAT RX KIT (KIT). DURING THE PROCEDURE, WHILE ADVANCING DOWN THE WIRE JUST PROXIMAL TO WHERE THE RAPID EXCHANGE PART BEGINS, THE PHYSICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE INDIGO SYSTEM CAT RX ASPIRATION CATHETER (CATRX) BECAME KINKED AND CONSEQUENTLY, THE CATRX WOULD NOT ASPIRATE. THEREFORE, THE CATRX WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6884515 ↗
• MalfunctionAug 10, 2017Bent; Aspiration Issue; Bent; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ULNAR ARTERY USING AN INDIGO SYSTEM CAT RX KIT (KIT). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE INDIGO SYSTEM CAT RX ASPIRATION CATHETER (CATRX) INTO THE TARGET VESSEL THROUGH A NON-PENUMBRA SHEATH AND OVER A NON-PENUMBRA WIRE. AFTER ASPIRATION WAS PERFORMED FOR A TOTAL OF THREE MINUTES IN THE ULNAR ARTERY, THE CATRX WAS REMOVED. THE PHYSICIAN DID NOT MENTION RESISTANCE DURING THE PROCEDURE; HOWEVER, ASPIRATION STOPPED. WHILE REMOVING THE CATRX FROM THE SHEATH, THE PHYSICIAN NOTICED THAT IT WAS BENT. THEREFORE, THE CATRX WAS SET ASIDE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) THROUGH THE SAME SHEATH AND OVER THE SAME WIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6785429 ↗
• MalfunctionAug 3, 2017Sticking; Physical Resistance; Material Deformation; Sticking; Physical Resistance; Material Deformation

  THE PATIENT WAS UNDERGOING THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT RX KIT (KIT). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE PERONEAL ARTERY USING AN INDIGO SYSTEM CAT RX ASPIRATION CATHETER (CAT RX) WITH A NON-PENUMBRA DESTINATION SHEATH AND A NON-PENUMBRA WIRE. IT WAS REPORTED THAT THE CAT RX WAS FLUSHED AFTER EACH PASS. WHILE ADVANCING THE CAT RX TO THE TARGET VESSEL FOR THE THIRD PASS UNDER ASPIRATION, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS ALSO REPORTED THAT THERE WAS CONSTANT BLOOD FLOW BUT THE CLOT WAS NEVER ENGAGED; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE CAT RX. HOWEVER, WHILE REMOVING THE CAT RX, THE CAT RX BEGAN STICKING ON THE WIRE AND THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PHYSICIAN PULLED THE CAT RX WITH THE WIRE ALL TOGETHER. IT WAS ALSO REPORTED THAT THE CAT RX PORT WAS BENDING LIKE AN ACCORDION WHEN REMOVING IT OVER THE WIRE OUTSIDE THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ONCE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6764522 ↗