LugeRecalls & reported problems across all models

We found 4 models of Luge by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2018 and Apr 23, 2025 — classified as 1 death, 24 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Luge problems

Luge models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Luge™ H7491213001J0

  WIRE, GUIDE, CATHETER
  1 death14 reports
• Luge™ H74912130010

  WIRE, GUIDE, CATHETER
  9 reports
• Luge™ H7491210001J0

  WIRE, GUIDE, CATHETER
  4 reports
• Luge™ H74912100010

  WIRE, GUIDE, CATHETER
  1 report

Recent Luge adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 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 ↗
• 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 ↗

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