LLD EZ Lead Locking DeviceRecalls & reported problems across all models

We found 2 models of LLD EZ Lead Locking Device by Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 345 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2018 and Sep 30, 2026 — classified as 19 deaths, 312 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (49 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 LLD EZ Lead Locking Device problems

LLD EZ Lead Locking Device models

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

• LLD EZ Lead Locking Device 518-062

  Stylet, Catheter
  18 deaths322 reports
• LLD EZ Lead Locking Device 518-067

  Stylet, Catheter
  1 death23 reports

Recent LLD EZ Lead Locking Device adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathSep 30, 2026Material Separation

  A lead extraction procedure commenced to remove a right ventricular (RV) lead due to fracture. A right atrial (RA) lead was present within the patient, but was not targeted for extraction. A Spectranetics LLD EZ Lead Locking Devices (LLD EZ) was inserted into the lead to provide traction. During extraction, utilizing multiple Spectranetics devices (GlideLight Laser Sheath, VisiSheath Dilator Sheath, TightRail Sub-C Rotating Dilator Sheath, and TightRail Rotating Dilator Sheath), the lead, along with the LLD broke in the subclavian. Switching to a Merit Medical Needle's Eye Snare, attempts were made to snare from the groin; however, the snare broke and a Abbott Agilis catheter was then used. After several attempts to dislodge the lead, a pericardial effusion was noted in the RV apex, and rescue efforts began, including pericardiocentesis and sternotomy. An RV perforation was discovered and repaired, and the RV lead was removed. The patient was transferred to the ICU in critical condition, and made no improvement in the following days. Care was withdrawn and the patient did not survive.This report captures the LLD that broke, and perforation occurred, requiring intervention, but resu

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50946464 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50938354 ↗
• InjurySep 29, 2026Entrapment of Device

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50937874 ↗
• InjurySep 17, 2026Material Separation

  Patient problems: Device Embedded In Tissue or Plaque; Hemodynamic instability; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50809096 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation

  MAUDE report 50805748 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right ventricular (RV) lead due to non-function. A Spectranetics LLD EZ Lead Locking Device (LLD EZ) was inserted into the lead to provide traction. Beginning with a Spectranetics GlideLight Laser Sheath, progress stalled above the superior vena cava (SVC), and pulling with traction forces from the LLD EZ, the RV lead came free. However, a pericardial effusion was detected, and rescue efforts began, including sternotomy. An RV perforation was discovered and repaired, and the RV lead was removed post-sternotomy with a Spectranetics TightRail Rotating Dilator Sheath. The patient survived the procedure.This report captures the LLD EZ providing traction on the RV 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 50805522 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right atrial (RA), right ventricular (RV), and left ventricular (LV) lead due to bacteremia. Spectranetics LLD EZ Lead Locking Devices (LLD EZs) were inserted into each lead to provide traction. Beginning with a Spectranetics 14F GlideLight Laser Sheath, along with a Spectranetics VisiSheath Dilator Sheath, advancement was made through the subclavian down past the RA. With traction from the LLD EZ, the LV lead was extracted; however, a pericardial effusion was detected. Rescue efforts began, including bypass, pericardial window, and sternotomy. A perforation to the coronary sinus (CS) was discovered and repaired (MDR #3007284006-2026-00431). The decision was made to abandon the extraction; therefore, the LLD EZs, along with the RA and RV lead, were cut and capped and remained in the patient (MDR #3007284006-2026-00432). There was no attempt made to unlock the LLD EZs. The patient survived the procedure.This report captures the LLD EZ within the RA lead, which was cut/capped and remained in the patient. There was no alleged malfunction of any Spectranetics devices in use during the procedure.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50498457 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50498454 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right atrial (RA), right ventricular (RV), and left ventricular (LV) lead due to bacteremia. Spectranetics LLD EZ Lead Locking Devices (LLD EZs) were inserted into each lead to provide traction. Beginning with a Spectranetics 14F GlideLight Laser Sheath, along with a Spectranetics VisiSheath Dilator Sheath, advancement was made through the subclavian down past the RA. With traction from the LLD EZ, the LV lead was extracted; however, a pericardial effusion was detected. Rescue efforts began, including bypass, pericardial window, and sternotomy. A perforation to the coronary sinus (CS) was discovered and repaired (MDR #3007284006-2026-00431). The decision was made to abandon the extraction; therefore, the LLD EZs, along with the RA and RV lead, were cut and capped and remained in the patient (MDR #3007284006-2026-00432, MDR #3007284006-2026-00433). There was no attempt made to unlock the LLD EZs. The patient survived the procedure.This report captures the LLD EZ providing traction when the perforation occurred, requiring intervention. There was no alleged malfunction of any Spectranetics devices in use during the procedure.

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 50498450 ↗
• InjuryAug 19, 2026Material Separation

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50330333 ↗
• DeathJul 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 25908907 ↗
• InjuryJun 22, 2026Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A CAPPED RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. AN ACTIVE RV AND ACTIVE RIGHT ATRIAL (RA) LEAD WERE PRESENT WITHIN THE PATIENT, BUT WERE NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION; HOWEVER, DURING PREPARATION OF THE CAPPED RV LEAD, THE HIGH VOLTAGE CABLES BROKE AT THE CLAVICLE AND PULLED OUT OF THE LEAD. ATTEMPTS WERE MADE TO ADVANCE TO THE LLD EZ, ONLY MAKING IT TO THE TOP OF THE SUPERIOR VENA CAVA (SVC). THE LLD EZ WAS RETRACTED AND A SPECTRANETICS LLD #1 LEAD LOCKING DEVICE (LLD #1) WAS USED WITH THE SAME RESULT, SO THE LLD #1 WAS REMOVED AND THE LLD EZ WAS INSERTED ONTO THE LEAD AGAIN, LOCKED, AND SUTURE WAS APPLIED TO THE OUTER INSULATION OF THE LEAD. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH, THE GLIDELIGHT WOULD NOT ADVANCE PAST THE CLAVICLE DUE TO SEVERE LEAD ON LEAD BINDING. THE DECISION WAS MADE TO ABANDON THE PROCEDURE FOR FEAR OF DAMAGING THE UNTARGETED LEADS. ATTEMPTS TO UNLOCK THE LLD EZ FROM THE CAPPED RV LEAD WERE UNSUCCESSFUL; THEREFORE, THE RV LEA

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25587720 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO FRACTURE AND OCCLUSION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ADVANCEMENT WAS MADE DOWN TO THE ATRIUM. WHILE PULLING ON THE LLD, THE LEAD PULLED BACK; HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED VIA ECHO. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. AN INFERIOR VENA CAVA (IVC)/RA JUNCTION PERFORATION WAS DISCOVERED, AND BELIEVED TO HAVE BEEN CAUSED BY PULLING ON THE LEAD, WHICH WAS ADHERED IN THE AREA CREATING THE PERFORATION. THE INJURY WAS REPAIRED, AND THE DECISION WAS MADE TO ABANDON THE PROCEDURE. THE LLD EZ, ALONG WITH THE RV LEAD, WERE CUT AND CAPPED, AND REMAINED IN THE PATIENT. THERE WAS NO ATTEMPT TO UNLOCK THE LLD EZ, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ PROVIDING TRACTION TO THE LEAD WHEN THE SUSPECTED PERFORATION OCCURRED, REQUIRING INTERVENTION, AND WAS CUT/CAPPED AND REMAINED IN THE PATIENT.

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Pericardial Effusion

  MAUDE report 25535493 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A LEFT VENTRICULAR (LV) LEAD DUE TO NON-FUNCTION. A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD WERE PRESENT WITHIN THE PATIENT BUT WERE NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS SMALL VISISHEATH DILATOR SHEATH, ADVANCEMENT WAS MADE TO THE DISTAL PORTION OF THE INNOMINATE JUST PRIOR TO THE SUPERIOR VENA CAVA (SVC). WITH TRACTION FROM THE LLD EZ, THE LEAD RETRACTED TO THE MID SVC. UPSIZING TO A 14F GLIDELIGHT, THE LEAD WAS EXTRACTED; HOWEVER, A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS. AN RV PERFORATION WAS SUSPECTED, BUT THE PATIENT STABILIZED AND SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ PROVIDING TRACTION TO THE 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 25504069 ↗
• MalfunctionJun 12, 2026Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH, THE RA AND LV LEADS WERE REMOVED SUCCESSFULLY. SWITCHING TO THE RV LEAD AND WHEN PULLING ON THE LLD EZ, THE LLD EZ BROKE PROXIMAL TO THE MANDREL. THE PHYSICIAN WAS STILL ABLE TO USE THE LLD EZ AND THE RV LEAD WAS REMOVED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES A PORTION OF THE LLD EZ THAT SEPARATED IN THE PATIENT; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490959 ↗

Other Spectranetics Corporation products

• GlideLight Laser Sheath3 models · 428 reports
• Turbo-Elite Laser Atherectomy Catheter12 models · 132 reports · 2 recalls
• TightRail Rotating Dilator Sheath5 models · 137 reports
• LLD #2 Lead Locking Device2 models · 72 reports
• AngioSculpt PTCA RX Scoring Balloon Catheter8 models · 55 reports
• ELCA Coronary Laser Atherectomy Catheter4 models · 42 reports
• TightRail Sub-C Rotating Dilator Sheath3 models · 32 reports
• Stellarex8 models · 27 reports