Luge™ H7491213001J0Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729169963), received between Aug 21, 2023 and Apr 3, 2024 — classified as 1 death, 13 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 182 CM LUGE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING REMOVAL, THE TIP OF THE WIRE WAS BROKEN AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19032661 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT MW5150888 THAT TIP DETACHMENT OCCURRED. TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) WAS PERFORMED. A GADANI WIRE WAS PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER, TRANSHEPATIC PORTAL WAS DIFFICULT TO ACCESS. SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. A 182CM LUGE GUIDEWIRES WERE SELECTED FOR USED. THREE OCCURRENCES WHERE THE TIP OF THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT. ON TWO OF THOSE OCCURRENCES, THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVED THE DEVICE, WHILE ON ONE OCCURRENCE; THE TIP OF THE WIRE HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. NO PATIENT COMPLICATIONS WERE REPORTED. THE REPORTED EVENT INFORMATION REFERENCES THREE OCCURRENCES CAPTURED IN EMDR 2124215-2024-07135 (17722511), EMDR 2124215-2024-07133 (17722598), AND EMDR 2124215-2024-07134 (17722711). FOLLOW-UP WAS SENT TO CLARIFY NUMBER OF EVENTS WAS SENT TO THE USER FACILITY WITH NO RESPONSE. THERE IS NO INDICATION OF A 4TH OCCURRENCE; MDR SUBMITTED IN ERROR.

  Patient problems: Foreign Body In Patient; Hematoma; Needle Stick/Puncture

  MAUDE report 18869206 ↗
• InjuryMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT MW5150887 THAT TIP DETACHMENT OCCURRED. TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) WAS PERFORMED. A GADANI WIRE WAS PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER, TRANSHEPATIC PORTAL WAS DIFFICULT TO ACCESS. SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. A 182CM LUGE GUIDEWIRES WERE SELECTED FOR USED. THREE OCCURRENCES WHERE THE TIP OF THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT. ON TWO OF THOSE OCCURRENCES, THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVED THE DEVICE, WHILE ON ONE OCCURRENCE; THE TIP OF THE WIRE HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. NO PATIENT COMPLICATIONS WERE REPORTED. THE RECORD IS A DUPLICATE OF EMDR 2124215-2024-07133 (17722598).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869204 ↗
• InjuryMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT MW5150890 THAT TIP DETACHMENT OCCURRED. TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) WAS PERFORMED. A GADANI WIRE WAS PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER, TRANSHEPATIC PORTAL WAS DIFFICULT TO ACCESS. SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. A 182CM LUGE GUIDEWIRES WERE SELECTED FOR USED. THREE OCCURRENCES WHERE THE TIP OF THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT. ON TWO OF THOSE OCCURRENCES, THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVED THE DEVICE, WHILE ON ONE OCCURRENCE; THE TIP OF THE WIRE HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. NO PATIENT COMPLICATIONS WERE REPORTED. THE REPORT IS A DUPLICATE OF EMDR 2124215-2024-07135 (17722511).

  Patient problems: Foreign Body In Patient

  MAUDE report 18869177 ↗
• InjuryMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT MW5150889 THAT TIP DETACHMENT OCCURRED. TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) WAS PERFORMED. A GADANI WIRE WAS PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER, TRANSHEPATIC PORTAL WAS DIFFICULT TO ACCESS. SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. A 182CM LUGE GUIDEWIRES WERE SELECTED FOR USED. THREE OCCURRENCES WHERE THE TIP OF THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT. ON TWO OF THOSE OCCURRENCES, THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVED THE DEVICE, WHILE ON ONE OCCURRENCE; THE TIP OF THE WIRE HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. NO PATIENT COMPLICATIONS WERE REPORTED. THE RECORD IS A DUPLICATE OF EMDR 2124215-2024-07134 (17722711).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869170 ↗
• DeathFeb 28, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DIED. A 2.75 X 8MM SYNERGY XD DRUG ELUTING-STENT AND LUGE GUIDEWIRE WERE USED DURING PROCEDURE. THE GUIDEWIRE BECAME STUCK ON THE STENT AND THE GUIDEWIRE SHEARED OFF IN THE STENT. ANOTHER STENT WAS PLACED TO TRAP THE GUIDEWIRE IN THE VESSEL WALL. THE PATIENT DIED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18796498 ↗
• InjuryFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE DETACHED WITHIN THE PATIENT. A LUGE GUIDEWIRE WAS SELECTED FOR USE DURING THE PROCEDURE. HOWEVER, THE TIP OF THE WIRE SHEARED OFF AND HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. NO FURTHER COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED VIA FACILITY MEDWATCH REPORT MW5150887 THAT TIP DETACHMENT OCCURRED. TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) WAS PERFORMED. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER, TRANSHEPATIC PORTAL WAS DIFFICULT TO ACCESS. SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. A 182CM LUGE GUIDEWIRES WERE SELECTED FOR USED. THREE OCCURRENCES WHERE THE TIP OF THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT. ON TWO OF THOSE OCCURRENCES, THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVED THE DEVICE, WHILE ON ONE OCCURRENCE; THE TIP OF THE WIRE HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682042 ↗
• InjuryFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 182CM J LUGE GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, THE TIP OF THE WIRE SHEARED OFF INSIDE THE PATIENT. THE PHYSICIAN SNARED THE TIP AND RETRIEVED IT. NO FURTHER COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED VIA FACILITY MEDWATCH REPORT MW5150890 THAT TIP DETACHMENT OCCURRED. TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) WAS PERFORMED. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER, TRANSHEPATIC PORTAL WAS DIFFICULT TO ACCESS. SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. A 182CM LUGE GUIDEWIRES WERE SELECTED FOR USED. THREE OCCURRENCES WHERE THE TIP OF THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT. ON TWO OF THOSE OCCURRENCES, THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVED THE DEVICE, WHILE ON ONE OCCURRENCE; THE TIP OF THE WIRE HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18678027 ↗
• InjuryFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. A LUGE GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, THE TIP OF THE WIRE SHEARED OFF INSIDE THE PATIENT. THE PHYSICIAN SNARED THE TIP AND RETRIEVED IT. NO FURTHER COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED VIA FACILITY MEDWATCH REPORT MW5150887 THAT TIP DETACHMENT OCCURRED. TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) WAS PERFORMED. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER, TRANSHEPATIC PORTAL WAS DIFFICULT TO ACCESS. SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. A 182CM LUGE GUIDEWIRES WERE SELECTED FOR USED. THREE OCCURRENCES WHERE THE TIP OF THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT. ON TWO OF THOSE OCCURRENCES, THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVED THE DEVICE, WHILE ON ONE OCCURRENCE; THE TIP OF THE WIRE HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677974 ↗
• InjuryJan 30, 2024

  THREE OCCURRENCES WHERE THE TIP OF CATHETER/GUIDEWIRE SHEARED OFF INSIDE OF THE PATIENT. ON TWO OF THOSE OCCURRENCES THE INTERVENTIONAL RADIOLOGIST WAS ABLE TO SNARE THE TIP AND RETRIEVE. ON ONE OCCURRENCE THE TIP THAT SHEARED OFF HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. DIFFICULT TRANSHEPATIC PORTAL ACCESS DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER. MULTIPLE PUNCTURES TO GET INTO PORTAL VEIN. "GADANI WIRE" PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. JUGULAR ACCESS WITH LIVERTY TIPS SET DURING ACCESS, SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. REFERENCE REPORTS: MW5150887, MW5150888, MW5150889.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 18613190 ↗
• InjuryJan 30, 2024

  THREE OCCURRENCES WHERE THE TIP OF CATHETER/GUIDEWIRE SHEARED OFF INSIDE OF THE PATIENT. ON TWO OF THOSE OCCURRENCES THE INTERVENTIONAL RADIOLOGIST WAS ABLE TO SNARE THE TIP AND RETRIEVE. ON ONE OCCURRENCE THE TIP THAT SHEARED OFF HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. DIFFICULT TRANSHEPATIC PORTAL ACCESS DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER. MULTIPLE PUNCTURES TO GET INTO PORTAL VEIN. "GADANI WIRE" PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. JUGULAR ACCESS WITH LIVERTY TIPS SET DURING ACCESS, SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. REFERENCE REPORTS: MW5150887, MW5150888, MW5150890.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 18613177 ↗
• InjuryJan 30, 2024

  THREE OCCURRENCES WHERE THE TIP OF CATHETER/GUIDEWIRE SHEARED OFF INSIDE OF THE PATIENT. ON TWO OF THOSE OCCURRENCES THE INTERVENTIONAL RADIOLOGIST WAS ABLE TO SNARE THE TIP AND RETRIEVE. ON ONE OCCURRENCE THE TIP THAT SHEARED OFF HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. DIFFICULT TRANSHEPATIC PORTAL ACCESS DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER. MULTIPLE PUNCTURES TO GET INTO PORTAL VEIN. "GADANI WIRE" PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. JUGULAR ACCESS WITH LIVERTY TIPS SET DURING ACCESS, SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. REFERENCE REPORTS: MW5150887, MW5150889, MW5150890.

  Patient problems: Foreign Body In Patient; Hematoma; Needle Stick/Puncture

  MAUDE report 18613161 ↗
• InjuryJan 30, 2024

  THREE OCCURRENCES WHERE THE TIP OF CATHETER/GUIDEWIRE SHEARED OFF INSIDE OF THE PATIENT. ON TWO OF THOSE OCCURRENCES THE INTERVENTIONAL RADIOLOGIST WAS ABLE TO SNARE THE TIP AND RETRIEVE. ON ONE OCCURRENCE THE TIP THAT SHEARED OFF HAD TO BE LEFT EMBEDDED IN THE LIVER PARENCHYMA. DIFFICULT TRANSHEPATIC PORTAL ACCESS DUE TO OBLITERATION OF PERIPORTAL FAT AND HETEROGENOUS LIVER. MULTIPLE PUNCTURES TO GET INTO PORTAL VEIN. "GADANI WIRE" PLACED AS A MARKER IN BOTH THE RIGHT AND MIDDLE HEPATIC PORTAL VEIN. JUGULAR ACCESS WITH LIVERTY TIPS SET DURING ACCESS, SOME INJECTIONS SEEMED TO BE WITHIN INTRAHEPATIC HEMATOMA. REFERENCE REPORTS: MW5150888, MW5150889, MW5150890.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 18613149 ↗
• InjuryAug 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH ARRHYTHMIA FOR BIVENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INSERTION. A 182 CM J LUGE GUIDEWIRE WAS SELECTED FOR USE IN PREPARING THE VESSEL FOR INSERTION OF A PACER LEAD. DURING WIRING USING THE 182CM J LUGE GUIDEWIRE, IT WAS NOTED THAT THE PROXIMAL PART OF THE RADIOPAQUE TIP HAD DETACHED. THE PHYSICIAN DECIDED TO LEAVE THE BROKEN PIECE INSIDE THE PATIENT AND NO REMOVAL ATTEMPTS WERE MADE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT WIRE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET VESSEL WAS IN THE POSTERIOR LATERAL BRANCH OF THE CORONARY SINUS, AND THAT THEY WERE UNABLE TO SAFELY REMOVE THE DEVICE DUE TO ITS LOCATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17590906 ↗