Luge™ H74912130010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729169956), received between Mar 6, 2019 and Apr 23, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 182CM LUGE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, THE GUIDEWIRE BECAME KINKED, AND ITS TIP CAME OFF INTO THE PATIENT. AN ATTEMPT WAS MADE TO SNARE THE DETACHED TIP, BUT IT WAS UNSUCCESSFUL. THE DETACHED TIP WAS LEFT IN THE VESSEL, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21889427 ↗
• InjuryJul 17, 2024Fracture; Fracture

  IT WAS REPORTED VIA USER FACILITY MEDWATCH (B)(4) THAT GUIDEWIRE FRACTURE OCCURRED. DURING THE INTRACARDIAC DEFIBRILLATOR INSERTION, A 182CM (5PK) LUGE GUIDEWIRE INTENDED TO LOCATE THE CORONARY SINUS BROKE OFF INSIDE THE PATIENT, LEAVING APPROXIMATELY 3CM OF THE FRAGMENT IRRETRIEVABLE. THE LUGE GUIDEWIRE WAS INTACT WHEN REMOVED FROM ITS PACKAGING, BUT THE END BROKE OFF WITHIN THE PATIENT DURING THE PROCEDURE. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19760881 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. A 182CM LUGE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, A 3 CM TIP OF THE GUIDEWIRE CAME OFF INTO THE CORONARY SINUS BRANCH. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264354 ↗
• InjuryFeb 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT 14797797086-2024-0001 THAT TIP DETACHMENT OCCURRED. A 182CM LUGE GUIDEWIRE WAS SELECTED FOR USED. HOWEVER, DURING PROCEDURE, THE TIP OF THE WIRE BROKE OFF INTO THE PATIENT. SURGICAL INTERVENTION WAS THEN PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DURING THE PROCEDURE, WHEN THE PHYSICIAN ENTERING THE CORONARY SINUS TO IMPLANT A PACEMAKER, THE WIRE WAS USED TO PROLAPSE BUT WHEN THE PHYSICIAN WAS READY TO PULL OUT THE LUGE WIRE, IT CAUGHT ON THE LEAD OR THE CATHETER WHICH THEN CREATED A COMPLETE SEPARATION OF THE RADIOPAQUE TIP FROM THE BODY OF THE WIRE. THE PHYSICIAN ATTEMPTED TO SNARE OUT THE TIP OF THE WIRE AND WAS UNSUCCESSFUL. THE MAIN BODY OF THE WIRE WAS REMOVED, AND THE RADIOPAQUE TIP OF THE WIRE WAS LEFT IN THE CORONARY SINUS OF THE PATIENT. THE PATIENT REMAINED STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18770139 ↗
• InjuryJun 29, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED VIA MEDWATCH (B)(4) AN ENTRAPMENT AND DETACHMENT OCCURRED. THE PATIENT PRESENTED FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 182CM LUGE GUIDEWIRE WERE SELECTED FOR USE. DURING PROCEDURE, A LUGE GUIDEWIRE GOT ENTRAPPED BETWEEN PREVIOUSLY IMPLANTED STENTS (YEARS AGO), THE DISTAL END OF THE GUIDEWIRE WAS DETACHED AND REMAINED IN THE DIAGONAL BRANCH OF THE LAD. ANOTHER STENT DEPLOYED IN AREA OF PREVIOUSLY IMPLANTED STENTS AND THE PROCEDURE COMPLETED WITH GOOD RESULTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND PATIENT TOLERATED WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 17224470 ↗
• InjuryJun 9, 2021Fracture; Fracture

  IT WAS REPORTED VIA USER MEDWATCH (B)(4) THAT TIP DETACHMENT OCCURRED. A LUGE GUIDEWIRE AND AN ACUITY PRO GUIDE CATHETER WERE IN USE AS PART OF A PROCEDURE IN THE ELECTROPHYSIOLOGY (EP) LAB. PART OF THE GUIDEWIRE BROKE OFF WHILE IN THE CORONARY SINUS AND COULD NOT BE RETRIEVED WITH A SNARE. THE WIRE WAS RETAINED IN THE HEART.

  Patient problems: Foreign Body In Patient

  MAUDE report 11970355 ↗
• MalfunctionNov 30, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DEVICE PACKAGE WAS UNSEALED. DURING UNPACKING OF A 182CM LUGE GUIDEWIRE, IT WAS NOTED THAT THE PACKAGE WAS OPENED AND THE INNER POUCH WAS COMPROMISED. NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10919196 ↗
• InjuryMar 3, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. A 182CM LUGE GUIDEWIRE WAS ADVANCED TO CROSS A LESION. HOWEVER, IT WAS NOTED THAT THE DISTAL TIP OF THE WIRE GOT CAUGHT ON THE DISTAL PORTION OF THE STENT. THE TIP OF THE WIRE REMAINED IN THE PATIENT AND ANOTHER STENT WAS PLACED AGAINST THE WALL TO TRAP THE WIRE SO IT WOULD NOT MOVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THIS ISSUE WAS REPORTED BY THE FACILITY ON A VOLUNTARY MEDWATCH/MAUDE REPORT # 2700040000-2020-8020. AFTER THE GUIDEWIRE WAS PLACED AND PRE-DILATED THE LESION WITH A BALLOON, A 3.0X24 SYNERGY DRUG-ELUTING STENT WAS IMPLANTED. HOWEVER, THE FLOW OF THE VESSEL WAS REMAINED SLOW AND SO THE GUIDEWIRE WAS REMOVED. DURING REMOVAL, A LITTLE RESISTANCE WAS ENCOUNTERED. A 2.75X20 STENT WAS PLACED AGAINST THE WALL TO TRAP THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9781431 ↗
• InjuryMar 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE DIAGONAL BRANCH AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. TWO 182CM LUGE GUIDEWIRES WAS USED TO CROSS THE LESION WITH ONE FOR DIAGONAL BRANCH AND ONE FOR LAD. INTERVENTION WAS COMPLETED. THE FIRST WIRE WAS PULLED OUT, BUT WHILE THE PHYSICIAN PULLED THE SECOND WIRE THERE WAS A DETACHED TIP LEFT IN LAD. IT WAS UNCERTAIN WHICH WIRE THE TIP DETACHED FROM. THE PROCEDURE WAS COMPLETED BY SUCCESSFULLY SNARING THE TIP AND WITH A USE OF A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394625 ↗