LumiGuide LumiGuide Navigation Wire 3D UltraRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884838111110), received between Jul 10, 2025 and Aug 11, 2026 — classified as 1 death, 6 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation of Vessels

  MAUDE report 50213290 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a LumiGuide wire was used in a Fenestrated and Branched Endovascular Repair procedure. The procedure was completed with no patient injury; however, during post-op CT, a possible dissection was noted where the LumiGuide was used in. The patient is fine, and was discharged from the hospital as expected.This Adverse Event is being submitted because the LumiGuide was used in the vessel, where a possible dissection occurred. There was no alleged malfunction with the LumiGuide Wire.

  Patient problems: Vascular Dissection

  MAUDE report 50064138 ↗
• DeathMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LUMIGUIDE WIRE WAS USED IN A FOUR-VESSEL PHYSICIAN-MODIFIED ENDOGRAFT (PMEG) PROCEDURE. DURING USE, THERE WERE NO SIGNS OF BLEEDING (POSSIBLY DUE TO AN ARTERIAL SPASM TEMPORARILY LIMITING OR OBSCURING THE BLEEDING), AND WHEN THE PATIENT LEFT THE OR, HE WAS IN STABLE CONDITION. HOWEVER, OVERNIGHT INTO THE NEXT MORNING, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND SWELLING, SUSPECTING A LEAK (PERFORATION), THUS REQUIRED EMERGENCY SURGERY. ON ANGIO, CONTRAST WAS POOLING TO THE RIGHT SUPERIOR MESENTERIC ARTERY (SMA), WHICH APPEARED TO BE EMANATING FROM A PROXIMAL BRANCH. THEREFORE, AN EXPLORATION OF MESENTERIC HEMATOMA WITH LIGATION OF BLEEDING BRANCHES AT THE ROOT AND A LIMITED TRANSVERSE COLECTOMY WERE PERFORMED. THEN, THE PATIENT WAS TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) ON PRESSORS AND ONGOING RESUSCITATION; UNFORTUNATELY, THE PATIENT EXPIRED THREE DAYS LATER ON (B)(6) 2026. FURTHER INFORMATION PROVIDED BY THE PHYSICIAN STATES, THE VESSEL DAMAGE COULD HAVE BEEN CAUSED BY THE LUMIGUIDE WIRE, CATHETER, OR AMPLATX WIRE, BUT IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE. ADDITIONALLY, THE PHYSICIAN USED A MODIFIED STENT GRAFT THAT WAS NOT AN OP

  Patient problems: Abdominal Pain; Hematoma; Perforation of Vessels

  MAUDE report 25072552 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LUMIGUIDE WIRE WAS USED IN A COMPLEX FEVAR PROCEDURE WITH FOUR FENESTRATIONS. THE CANNULATION OF THE SUPERIOR MESENTERIC ARTERY (SMA) WAS DIFFICULT, RESULTING IN FEW ATTEMPTS WITH DIFFERENT CATHETERS. DURING THE FINAL ANGIOGRAM, A DISSECTION WAS NOTED IN THE SMA, BUT WAS COVERED WITH STENTS. THE DISSECTION SEEMED TO ORIGINATE MORE DISTAL THAN WHERE THE LUMIGUIDE WAS EVER USED; THUS, LIKELY OCCURRED DURING MANIPULATION OF A CATHETER IN COMBINATION WITH A TERUMO WIRE; HOWEVER, CANNOT BE CERTAIN. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE LUMIGUIDE WAS IN USE WHEN A DISSECTION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE LUMIGUIDE WIRE.

  Patient problems: Vascular Dissection

  MAUDE report 24512704 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LUMIGUIDE WIRE WAS USED IN A F/BEVAR PROCEDURE. DURING USE, A DISSECTION WAS NOTED IN THE RIGHT RENAL ARTERY, AND WAS COVERED WITH A STENT. THE PATIENT WAS DISCHARGED AND OUTCOME IS FINE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE LUMIGUIDE WAS IN USE WHEN A DISSECTION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE LUMIGUIDE WIRE.

  Patient problems: Vascular Dissection

  MAUDE report 24345535 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LUMIGUIDE WIRE WAS USED IN AN AORTIC PROCEDURE. THE LUMIGUIDE WAS LOADED WITH A NON-PHILIPS GUIDE CATHETER AND INSERTED INTO A NON-PHILIPS STEERABLE SHEATH, THEN ADVANCED TO THE RIGHT RENAL ARTERY (RAA). DURING CANNULATION OF THE RRA, RESISTANCE WAS ENCOUNTERED AT THE CURVE. CHECKING WITH CONTRAST, A DISSECTION WAS NOTED, AND WAS TREATED WITH THE ORIGINAL PLANNED PROCEDURE BY BRIDGING A STENT. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE LUMIGUIDE WAS IN USE WHEN A DISSECTION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE LUMIGUIDE.

  Patient problems: Vascular Dissection

  MAUDE report 24192718 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LUMIGUIDE WAS USED IN A FEVAR PROCEDURE IN A MODERATELY CALCIFIED AND TORTUOUS LEFT RENAL ARTERY. MULTIPLE STENTS WERE PLACED IN CONJUNCTION WITH THE FEVAR GRAFT TO PROVIDE A GOOD SEAL ZONE OF THE RENAL ARTERY AND AORTA. HOWEVER, WHEN CANNULATING WITH THE LUMIGUIDE, A DISSECTION WAS NOTED; THEREFORE, AN ADDITIONAL UNCOVERED STENT WAS PLACED DISTAL TO THE FRESHLY DEPLOYED STENTS IN THE RENAL ARTERY. THE CASE PROGRESSED AS NORMAL, AND FINAL ANGIOGRAM SHOWED BETTER BLOOD FLOW FROM THE KIDNEY TO THE LEFT RENAL ARTERY. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE LUMIGUIDE WAS IN USE WHEN A DISSECTION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE LUMIGUIDE WIRE.

  Patient problems: Vascular Dissection

  MAUDE report 22469232 ↗