LLD #2 Lead Locking Device 518-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00813132023027), received between Mar 29, 2019 and Mar 1, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2023Adverse 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 CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. WHILE ATTEMPTING TO REMOVE THE RA LEAD WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WITH ITS OUTER SHEATH, FOUR ATTEMPTS AT ADVANCEMENT OCCURRED THROUGH THE PATIENT'S SUPERIOR VENA CAVA (SVC) REGION BEFORE THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS COMMENCED IMMEDIATELY, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, AND STERNOTOMY. PERFORATIONS WERE DISCOVERED IN THE SVC (MDR #1721279-2023-00028) AND THE RV AND WERE REPAIRED. THE PHYSICIAN BELIEVED THAT OVER THE YEARS, THE RA LEAD MIGRATED EXTRAVASCULAR WITHIN THE SVC, AS OBSERVED DURING THE REPAIR. THE RV PERFORATION OCCURRED DURING THE PERICARDIOCENTESIS, UNRELATED TO ANY SPECTRANETICS DEVICE. THE RA AND RV LEADS WERE NOT REMOVED. THE PHYSICIAN DID NOT ATTEMPT TO UNLOCK EITHER LLD PRIOR TO CUTTING AND CAPPING THE LLDS WITHIN THE LEADS; BOTH LEADS/LLDS REMAINED WITHIN THE PATIENT (MDR #1721279-2023-00029 FOR RA LEAD/LLD, THIS REPORT FOR RV LEAD/LLD). THE PATIENT SURVIVED THE PROCEDURE, RECO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16461099 ↗
• InjuryMar 1, 2023Adverse 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 CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. WHILE ATTEMPTING TO REMOVE THE RA LEAD WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WITH ITS OUTER SHEATH, FOUR ATTEMPTS AT ADVANCEMENT OCCURRED THROUGH THE PATIENT'S SUPERIOR VENA CAVA (SVC) REGION BEFORE THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS COMMENCED IMMEDIATELY, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, AND STERNOTOMY. PERFORATIONS WERE DISCOVERED IN THE SVC (MDR #1721279-2023-00028) AND THE RV AND WERE REPAIRED. THE PHYSICIAN BELIEVED THAT OVER THE YEARS, THE RA LEAD MIGRATED EXTRAVASCULAR WITHIN THE SVC, AS OBSERVED DURING THE REPAIR. THE RV PERFORATION OCCURRED DURING THE PERICARDIOCENTESIS, UNRELATED TO ANY SPECTRANETICS DEVICE. THE RA AND RV LEADS WERE NOT REMOVED. THE PHYSICIAN DID NOT ATTEMPT TO UNLOCK EITHER LLD PRIOR TO CUTTING AND CAPPING THE LLDS WITHIN THE LEADS; BOTH LEADS/LLDS REMAINED WITHIN THE PATIENT (THIS REPORT FOR RA LEAD/LLD, MDR #1721279-2023-00030 FOR RV LEAD/LLD). THE PATIENT SURVIVED THE PROCEDURE, RECO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16461097 ↗
• InjuryDec 15, 2022Adverse 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 BACTEREMIA/CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN BEGAN BY ATTEMPTING EXTRACTION OF THE RA LEAD USING A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH, AND PROGRESS STALLED AT THE INNOMINATE VEIN. THE GLIDELIGHT''S OUTER SHEATH WAS ADDED, STALLING AT THE SUPERIOR VENA CAVA (SVC) JUNCTION, WITH LEAD ON LEAD BINDING NOTED. THE PHYSICIAN SWITCHED EFFORTS TO THE RV LEAD. USING THE 12F GLIDELIGHT WITH THE OUTER SHEATH, PROGRESS STALLED AT THE SVC JUNCTION. THE PHYSICIAN THEN USED A COOK MEDICAL 10F BYRD DILATOR SHEATH. THE LLD CAME OUT OF THE RV LEAD, AND A NEW LLD WAS INSERTED. REMOVAL EFFORTS FOCUSED BACK ON THE RA LEAD. USING THE BYRD DEVICE, THE LEAD BINDING WAS STRIPPED OFF AT THE SVC JUNCTION, AND THE TIP OF THE RA LEAD RELEASED AND WAS REMOVED. THE PATIENT''S BLOOD PRESSURE DRIFTED DOWNWARD, AND A PERICARDIAL EFFUSION WAS DETECTED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS (UNSUCCESSFUL BECAUSE BLOOD HAD CLOTTED), PERCUTANEOUS CARDI

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 15987571 ↗
• InjuryAug 31, 2022Adverse 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 CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. USING A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, THE PHYSICIAN EXTRACTED THE RA LEAD; HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED. THE PATIENT WAS STABLE AND THE PHYSICIAN CONTINUED THE PROCEDURE AND SUCCESSFULLY REMOVED THE RV LEAD USING THE 11F TIGHTRAIL AND A 13F TIGHTRAIL. AT THE END OF THE PROCEDURE, THE SURGEON PERFORMED A PERICARDIOCENTESIS. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD PRESENT IN THE RA LEAD WHEN A RIGHT ATRIAL 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 15331457 ↗
• InjuryDec 16, 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 INFECTION. THE RV LEAD WAS SUCCESSFULLY REMOVED. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION. THE PHYSICIAN ATTEMPTED EXTRACTION OF THE RA LEAD USING A COOK MEDICAL 9F EVOLUTION MECHANICAL DILATOR SHEATH AND A SPECTRANETICS GLIDELIGHT LASER SHEATH, BUT COULD NOT REMOVE IT BECAUSE OF STRONG ADHESION. THE PHYSICIAN THEN USED A COOK MEDICAL NEEDLE'S EYE SNARE AND CAUGHT THE VICINITY OF THE LEAD TIP, AND USING THE EVOLUTION DEVICE, THE LEAD WAS REMOVED. AFTER RA LEAD REMOVAL, THE PATIENT'S BLOOD PRESSURE DROPPED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED AN ACCUMULATION OF PERICARDIAL FLUID (EFFUSION). ALTHOUGH DRAINAGE WAS DONE, THE PATIENT'S CONDITION DID NOT IMPROVE. THE PHYSICIAN PERFORMED A STERNOTOMY AND SURGERY WAS PERFORMED (SPECIFIC PERFORATION LOCATION AND INTERVENTION UNK). THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD PROVIDING TRACTION TO THE RA LEAD WHEN CARDIAC TAMPONADE OCCURRED RESULTING FROM A PERFORATION, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 13022483 ↗
• InjuryFeb 15, 2021Mechanical Problem; Mechanical Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) LEAD, A LEFT VENTRICULAR (LV) LEAD AND A RIGHT VENTRICULAR (RV) LEAD WITH A HYBRID APPROACH OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO POCKET DECUBITUS. THE PHYSICIAN WAS ABLE TO EXTRACT THE LV LEAD USING A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH. THE RA LEAD WAS REMOVED WITH USE OF A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, AFTER ATTEMPTS WERE MADE USING 11F AND 13F TIGHTRAIL DEVICES. THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH EXTRACTION OF THE RV LEAD USING THE ABOVEMENTIONED DEVICES, ALONG WITH A SPECTRANETICS LEAD LOCKING DEVICE (LLD) THAT WAS INSERTED INTO THE RV LEAD AND WAS PROVIDING TRACTION TO AID IN EXTRACTION. AFTER SEVERAL ATTEMPTS TO REMOVE THE RV LEAD, THE PHYSICIAN DECIDED TO ABANDON IT WITHIN THE PATIENT. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE LLD FROM INSIDE THE LUMEN OF THE RV LEAD, SO THE PHYSICIAN CUT BOTH THE RV LEAD AND THE LLD CONTAINED WITHIN THE LEAD, AND CAPPED THEM. THE PHYSICIAN THEN SUCCESSFULLY REIMPLANTED THE CRT-D SYSTEM FROM THE PATIENT'S LEFT SIDE. THE PATIENT SURVIVED THE PROCEDURE AND THERE WAS NO REPORTED INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 11329848 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO INFECTION. A LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO EACH LEAD TO ACT AS A TRACTION PLATFORM TO AID IN EXTRACTION. USING A SPECTRANETICS GLIDELIGHT LASER SHEATH, THE PHYSICIAN REMOVED THE RV LEAD WITHOUT DIFFICULTY. HOWEVER, AFTER EXTRACTION OF THE RA LEAD, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. INJURIES TO THE ATRIUM AND TO THE POSTERIOR SUPERIOR VENA CAVA (SVC) WERE DISCOVERED. THESE AREAS WERE REPAIRED SUCCESSFULLY, EPICARDIAL LEADS WERE USED TO STIMULATE THE HEART, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD, PRESENT WITHIN AND PROVIDING TRACTION FOR EXTRACTION OF THE RA LEAD, AT THE TIME OF THE ATRIAL INJURY. THE SVC INJURY IS CAPTURED IN MDR #1721279-2020-00144, INVOLVING USE OF THE GLIDELIGHT DEVICE IN THE AREA OF THE SVC.

  Patient problems: Atrial Perforation; Great Vessel Perforation; Iatrogenic Source

  MAUDE report 10311671 ↗
• InjuryJun 26, 2019Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IN THE PREVIOUS MDR REPORT, IT WAS REPORTED THAT THE 20 YEAR OLD RV LEAD(5092) WAS BEING REMOVED WHEN THE LEAD SNAPPED, ALONG WITH THE LLD. THIS HAS BEEN REPORTED TO NOT BE THE CASE. IN SUBSEQUENT CONVERSATIONS ON (B)(6) 2019 WITH THE REP WHO WAS PRESENT IN THE CASE, LEAD EXTRACTION INFORMATION WAS CLARIFIED. HE REPORTED THAT LEAD 5092 RV LEAD (228 MO IMPLANT) WAS REMOVED DURING THE LEAD EXTRACTION PROCEDURE WITHOUT ISSUE. IT WAS REPORTED THAT THE 4524 RA LEAD (324 MO IMPLANT) WAS THE ONE IN WHICH THE LEAD SNAPPED ALONG WITH THE LLD WHICH WAS IN THE LEAD. THE 4024 RV LEAD (324 MO IMPLANT) WOULD NOT RELEASE DESPITE ATTEMPTS TO DO SO. THE 4524 RA LEAD ALONG WITH THE LLD WAS CAPPED FOR PLANNED REMOVAL THE NEXT DAY; THE 4024 RV LEAD ALONG WITH AN LLD PRESENT WITHIN THE LEAD, WAS CUT/CAPPED AS WELL, AND BOTH OF THESE LEADS WERE REMOVED IN AN OPEN HEART PROCEDURE THAT OCCURRED ON (B)(6) 2019. ALSO CLARIFIED THAT THE 4524 RA LEAD (AND THE LLD) SNAPPED NEAR THE END OF THE INNOMINATE VEIN, NEAR THE SVC. THE PATIENT''S SUBSEQUENT REPORTED DEATH ON (B)(6) 2019 WAS NOT RELATED TO THE LEAD/LLD SNAPPING.

  Patient problems: Death; Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 8736448 ↗
• InjuryApr 9, 2019Mechanical Problem; Mechanical Problem

  A PHILIPS REPRESENTATIVE REPORTED THAT A CARDIAC LEAD MANAGEMENT PROCEDURE COMMENCED TO REMOVE 4 NON-FUNCTIONAL LEADS. 2 RIGHT VENTRICULAR (RV), 1 LEFT VENTRICULAR (LV) AND 1 RIGHT ATRIAL (RA) WERE INTENDED FOR REMOVAL. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) #2 WAS INSERTED TO FACILITATE ATRIAL LEAD EXTRACTION. DURING THE PROCEDURE A VESSEL PERFORATION OCCURRED, RESCUE INTERVENTIONS WERE IMPLEMENTED AND THE PATIENT WAS STABILIZED (SEE MDR 1721279-2019-00029 FOR FURTHER DETAIL REGARDING VESSEL PERFORATION). NO LEADS WERE ABLE TO BE REMOVED. HOWEVER, NEW RV AND RA LEADS WERE SUCCESSFULLY IMPLANTED. THE PHYSICIAN CUT THE LLD, AND A PORTION OF THE LLD REMAINED IN THE LEAD WHEN IT WAS CUT.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 8496747 ↗
• InjuryMar 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A LEAD MANAGEMENT PROCEDURE TO REMOVE A NON-FUNCTIONAL RIGHT VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD A SPECTRANETICS LEAD LOCKING DEVICE #2 (LLD) 518-022 WAS UTILIZED. THROUGHOUT THE PROCEDURE THE BLOOD PRESSURE DROPPED AND RECOVERED SEVERAL TIMES. THE PHYSICIAN WOULD RELAX HIS TRACTION AND THE BLOOD PRESSURE WOULD RECOVER. IT APPEARED THE PRESSURE DROP WAS DUE TO THE INVERSION OF THE RIGHT VENTRICLE (RV) WHILE APPLYING TENSION ON THE LEAD WITH THE LLD. THE PATIENT'S BLOOD PRESSURE DROPPED AGAIN, BUT DID NOT RECOVER AND RESCUE INTERVENTIONS WERE REQUIRED (SEE MDR 1721279-2019-00060 WHICH COVERS THE DEVICE IN USE DURING THIS PART OF THE PROCEDURE AS WELL AS PATIENT INJURY). THE LEAD LOCKING DEVICE WAS CUT AND CAPPED WITHIN THE LEAD. THIS MDR IS BEING SUBMITTED TO CAPTURE THE LLD CUT AND CAP WITHIN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 8466110 ↗