LLD #1 Lead Locking Device 518-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813132022990), received between May 25, 2018 and Jul 3, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 16, 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.

• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO (ONE CAPPED AND ONE ACTIVE) RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS DUE TO NON-FUNCTION AND OCCLUSION. SPECTRANETICS LLD #1 LEAD LOCKING DEVICES (LLD #1S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH ON THE CAPPED RV LEAD, THE LEAD WAS REMOVED SUCCESSFULLY. NEXT, USING THE SAME 11F TIGHTRAIL, THE RA LEAD WAS REMOVED; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, AND STERNOTOMY. A PERFORATION IN THE RA WAS DISCOVERED AND REPAIRED. THE REMAINING RV LEAD WAS REMOVED POST-STERNOTOMY USING A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD #1 DEVICE PROVIDING TRACTION TO THE RA LEAD WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 22396507 ↗
• InjurySep 14, 2024Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION AND SUSPECTED LEAD FRACTURE. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD #1 LEAD LOCKING DEVICE (LLD #1) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. HOWEVER, ADVANCEMENT COULD ONLY BE MADE TO THE MID SUPERIOR VENA CAVA (SVC) REGION, LIKELY DUE TO LEAD FRACTURE, AND THE LLD CRIMPED DUE TO EXCESSIVE FORCE IN ATTEMPTS TO ADVANCE DOWN THE LEAD. THEREFORE, A SECOND LLD #1 WAS ADVANCED TO THE MID SVC AND LOCKED IN PLACE. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, SEVERE CALCIFICATION WAS ENCOUNTERED AND PROGRESS STALLED IN THE MID SUBCLAVIAN REGION. NEXT, A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH WAS ADVANCED TO THE INNOMINATE/SVC JUNCTION. SWITCHING BACK TO THE 14F GLIDELIGHT, NO FURTHER PROGRESS WAS ACHIEVED. THEN, A 16F GLIDELIGHT WAS USED TO GET OVER THE CALCIUM, AND ADVANCEMENT WAS MADE TO THE TOP OF THE SVC. HOWEVER, TRACTION DID NOT STRAIGHTEN OUT THE LEAD FROM THE SVC LATERAL WALL, AND THE RV AND RA LEADS WERE CROSSED FROM THE LEFT INNOMINATE TO THE SVC. THE LEADS THEN M

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20219006 ↗
• InjuryOct 11, 2022Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN USED A SPECTRANETICS GLIDELIGHT LASER SHEATH TO SUCCESSFULLY EXTRACT THE RA LEAD. WHILE ATTEMPTING REMOVAL OF THE RV LEAD, THE PHYSICIAN WAS USING A HEMOSTAT CLAMPED ON TO THE LLD MANDREL FOR ADDITIONAL TRACTION (WHICH IS COMMON PRACTICE AND PHYSICIAN PREFERENCE), AND AFTER PULLING SEVERAL TIMES, THE RV LEAD AND LLD BROKE AT THE REGION WHERE THE LLD WAS CLAMPED. THE PHYSICIAN CHOSE NOT TO FURTHER ATTEMPT REMOVAL OF THE RV LEAD. THE PHYSICIAN COULD NOT ATTEMPT TO UNLOCK THE LLD FROM THE LEAD DUE TO THE LLD BREAKING; THE LEAD AND LLD WITHIN WAS CUT AND CAPPED AND REMAINED IN THE PATIENT. THERE WAS NO REPORTED PATIENT HARM AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD PRESENT WITHIN THE RV LEAD WHICH BROKE ALONG WITH THE LEAD, AND WAS CUT AND CAPPED AND REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15575814 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) LEADS (ONE CAPPED, ONE ACTIVE) AND A RIGHT ATRIAL (RA) LEAD. THE PATIENT NO LONGER NEEDED THE DEVICE AND WANTED IT REMOVED. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. IT WAS NOTED THAT ALL THREE LEADS WERE BOUND TOGETHER IN THE RA. USING SPECTRANETICS GLIDELIGHT LASER SHEATH AND SPECTRANETICS VISISHEATH DILATOR SHEATH DEVICES, THE ACTIVE RV LEAD WAS SUCCESSFULLY REMOVED FIRST. SECOND, THE CAPPED RV WAS SUCCESSFULLY REMOVED. THE RA LEAD WAS IN THE RIGHT ATRIAL APPENDAGE AND ONCE REMOVED, THE PATIENT''S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS SEEN VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND A PERICARDIOCENTESIS WAS PERFORMED, ALONG WITH A DRAIN. HOWEVER, THE EFFUSION WAS NOT GOING DOWN. A STERNOTOMY FOLLOWED AND A RIGHT ATRIAL APPENDAGE PERFORATION WAS DISCOVERED. THE REPAIR WAS SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD PROVIDING TRACTION TO THE RA LEAD WHEN THE RIGHT ATRIAL APPENDAGE OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 13864560 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. THE PHYSICIAN USED A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH ALONG WITH THE LLD AND THE RV LEAD WAS REMOVED SUCCESSFULLY. HOWEVER, WHEN THE LEAD CAME OUT OF THE BODY IT WAS NOTED THAT THERE WAS PART OF THE TRICUSPID LEAF THAT CAME OUT ALONG WITH THE LEAD. NO HEMODYNAMIC CHANGES WERE NOTED IN THE PATIENT. THE RA LEAD WAS THEN SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED AND THE PATIENT SURVIVED. THE SURGEON IS GOING TO DO A TRICUSPID VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) ON THIS PATIENT AT A LATER TIME, SO TRICUSPID REGURGITATION IS SUSPECTED. THIS REPORT CAPTURES THE LLD PROVIDING TRACTION TO THE RV LEAD WHEN PART OF THE TRICUSPID LEAF CAME OUT ALONG WITH THE LEAD. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 12587111 ↗
• MalfunctionSep 11, 2020Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. THE PHYSICIAN CHOSE A SPECTRANETICS LEAD LOCKING DEVICE (LLD) TO ACT AS THE TRACTION PLATFORM TO AID IN LEAD EXTRACTION. HOWEVER, AFTER HE HAD INSERTED THE LLD INTO THE LEAD AND ATTEMPTED TO ENGAGE THE LOCKING MECHANISM, THE LLD BROKE INTO TWO PIECES. THE PHYSICIAN THEN CHOSE TO USE A COOK MEDICAL BULLDOG LEAD EXTENDER AND SUTURE TO ACT AS TRACTION PLATFORMS INSTEAD WITH NO DISRUPTION IN CASE FLOW, AND SUCCESSFULLY COMPLETED THE CASE WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THIS EVENT WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10521147 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Iatrogenic Source; Perforation of Vessels

  MAUDE report 7546805 ↗