GlideLight Laser SheathRecalls & reported problems across all models

We found 3 models of GlideLight Laser Sheath by Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 428 adverse event reports in the FDA's MAUDE database, received between Apr 13, 2018 and Sep 29, 2026 — classified as 105 deaths, 253 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Material Separation” (35 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 GlideLight Laser Sheath problems

GlideLight Laser Sheath models

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

• GlideLight Laser Sheath 500-303

  Device, Removal, Pacemaker Electrode, Percutaneous
  63 deaths221 reports
• GlideLight Laser Sheath 500-302

  Device, Removal, Pacemaker Electrode, Percutaneous
  39 deaths180 reports
• GlideLight Laser Sheath 500-301

  Device, Removal, Pacemaker Electrode, Percutaneous
  3 deaths27 reports

Recent GlideLight Laser Sheath adverse event reports

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

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Great Vessel Perforation; Perforation of Vessels; Pericardial Effusion

  MAUDE report 50938355 ↗
• MalfunctionSep 17, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 50809413 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove two right ventricular (RV) (left and right side) and two right atrial (RA) leads (left and right side) due to bacteremia. Spectranetics LLD Lead Locking Devices (LLDs) was inserted into each lead to provide traction. Beginning with a Spectranetics 14F GlideLight Laser Sheath on the left RV lead, adhesions in the vasculature were removed. Switching to a Spectranetics 13F TightRail Sub-C Rotating Dilator Sheath, the left RV and left RA lead were removed successfully. Next, a Spectranetics 16F GlideLight Laser Sheath was used on both the right RV and right RA. When lasing on the right RV lead, the patient's blood pressure dropped and a pericardial effusion was detected via transesophageal echocardiogram (TEE). Rescue efforts began, including rescue balloon, CPR, and sternotomy. A perforation at the inferior vena cava (IVC)/RA junction into the RA was discovered and repaired; however the patient did not survive procedure, and the right RA and RV lead remained in the patient.This report captures the 16F GlideLight in use when the perforation occurred, requiring intervention, but resulting death. There was no alleged malfunction of any Spec

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

  MAUDE report 50803939 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation

  MAUDE report 50796787 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 50329261 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right ventricular (RV) and right atrial (RA) leads due to non-function. Spectranetics LLD EZ Lead Locking Devices (LLD EZs) were inserted into each lead to provide traction. Beginning with a Spectranetics 14F GlideLight Laser Sheath on both leads, significant adhesions were encountered. Switching to a Spectranetics 13F TightRail Sub-C Rotating Dilator Sheath, advancement was made through the subclavian region. Next, utilizing the 14F GlideLight, progress remained challenging due to the extensive adhesions and lead on lead binding. Upsizing to a Spectranetics 16F GlideLight Laser Sheath, gradual advancement was made to the distal coil of the RV lead. With traction from the LLD EZ, the RV lead was removed; however, the patient's blood pressure dropped and rescue efforts began, inlcuding CPR, pericardiocentisis, and sternotomy. An RV perforation was discovered, and repaired, and the RA lead was removed post-sternotomy. The patient survived the procedure. This report captures the GlideLight in use when the perforation occurred, requiring intervention. There was no alleged malfunction of any Spectranetics devices in use during the proced

  Patient problems: Cardiac Perforation

  MAUDE report 50221178 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON BOTH LEADS, MODERATE CALCIFICATIONS WERE CLEARED. NEXT, UTILIZING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RV LEAD, ADVANCEMENT WAS MADE TO THE DISTAL COIL WHEN TISSUE PLOWING OCCURRED, AND UPSIZED TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, CLEARING THE DISTAL COIL, BUT NOT FURTHER BEYOND. THEREFORE, TARGETING THE RA LEAD, THE 14F GLIDELIGHT WAS USED AND PROGRESS WAS MADE TO THE RA DISTAL TIP, AND THE COIL WAS FREED FROM THE HEART. STILL EXPERIENCING SOME RESISTANCE, LASING CONTINUED, AND WITH FURTHER TRACTION, THE LEAD PULLED BACK IN THE 14F GLIDELIGHT AND WAS EXTRACTED. HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY, AND AN RA PERFORATION WAS DISCOVERED AND REPAIRED. THE RV LEAD WAS REMOVED POST-STERNOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THI

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 25734827 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH, THE RA LEAD WAS REMOVED SUCCESSFULLY. SWITCHING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH ON THE RV LEAD, PROGRESS WAS MADE THROUGH THE INNNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION WHEN RESISTANCE WAS ENCOUNTERED AT THE SVC/RA JUNCTION AND ADVANCEMENT STALLED. THE PATIENT'S BLOOD PRESSURE DROPPED AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE RV LEAD WAS REMOVED POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 25588217 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO FRACTURE. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING MULTIPLE SPECTRANETICS DEVICES (12F GLIDELIGHT LASER SHEATH, 14F GLIDELIGHT LASER SHEATH, 16F GLIDELIGHT LASER SHEATH, 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, AND 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH) THE RV AND RA LEADS WERE REMOVED. POST-EXTRACTION, THE INITIAL TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS NEGATIVE FOR AN EFFUSION; HOWEVER, SEVERAL MINUTES LATER AFTER A REPEAT TEE, A SMALL PERICARDIAL EFFUSION WAS DETECTED. UNDER CONTINUED MONITORING, IT WAS NOTED THAT THE PERICARDIAL EFFUSION HAD GROWN, AND RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 12F GLIDELIGHT IN USE WHEN A PERICARDIAL EFFUSION OCCURRED POST-PROCEDURE, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 25588088 ↗
• InjuryApr 7, 2026Adverse 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. THE RV LEAD WAS AN ADVISORY RIATA LEAD THAT SHOWED OBVIOUS CABLE EXTERNALIZATION UNDER PRE-CASE X-RAY AND FLUORO. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THE RA LEAD WAS SUCCESSFULLY REMOVED. TARGETING THE RV LEAD WITH THE SAME TIGHTRAIL, IT PROGRESSED THROUGH THE SUBCLAVIAN; HOWEVER, STOPPED AT THE INNOMINATE/SUPERIOR VENA CEVA (SVC) JUNCTION. SWITCHING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, PROGRESS WAS MADE THROUGH THE SVC AND IN TO THE HEART, BUT STALLED AT THE POINT WHERE THE CABLE EXTERNALIZATION OCCURRED BETWEEN THE TWO SHOCKING COILS. ATTEMPTING TO PULL THE GLIDELIGHT OFF TO POSSIBLY UTILIZE A SPECTRANETICS VISISHEATH DILATOR SHEATH, IT WAS NOTED THAT THE RV LEAD WAS FREE FROM THE VENTRICLE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED THE LEAD WAS FREE FROM THE APEX. HIGH VOLTAGE CABLES WERE PULLED DIRECTLY FROM THE POCKET INTO THE LEAD BODY, WHILE THE GLIDELIGHT WAS OFF THE LEAD AND OUTSIDE THE BODY. BECAUSE THE

  Patient problems: Great Vessel Perforation; Perforation of Vessels; Pericardial Effusion

  MAUDE report 24811248 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS VISISHEATH DILATOR SHEATH ON THE RA LEAD, PROGRESS WAS MADE TO THE SUPERIOR VENA CAVA (SVC) WHEN BINDING WAS ENCOUNTERED. WHEN TRYING TO PUSH THROUGH THE CALCIFICATION, THE PATIENT¿S BLOOD PRESSURE DROPPED AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE LEADS WERE REMOVED POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 24783762 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE RV LEAD WAS SUCCESSFULLY REMOVED. WHEN REMOVING THE RA LEAD, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A PERFORATION IN THE SUPERIOR VENA CAVA (SVC) WAS DISCOVERED AND REPAIRED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT IN USE WHEN THE PERFORATIONS OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 24781294 ↗
• InjuryMar 30, 2026Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. A RIGHT ATRIAL (RA) LEAD WAS PRESENT WITHIN THE PATIENT BUT WAS NOT TARGETED FOR EXTRACTION. A COOK MEDICAL LIBERATOR LOCKING STYLET WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH, ADVANCEMENT WAS MADE TO THE PROXIMAL COIL OF THE LEAD, AND STALLED. HOWEVER, WHEN ATTEMPTING TO RETRACT THE DEVICE, IT BECAME STUCK AND WITH TRACTION APPLIED TO THE GLIDELIGHT, THE PATIENT¿S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS NOTED. UTILIZING A SNARE, ATTEMPTS TO REMOVE THE GLIDELIGHT WERE UNSUCCESSFUL, AND THE PERICARDIAL EFFUSION WAS GROWING. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY, AND AN RV PERFORATION WAS DISCOVERED AND REPAIRED. THE GLIDELIGHT WAS REMOVED, AND THE RV LEAD WAS EXTRACTED USING A COOK MEDICAL BYRD DILATOR SHEATH POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 12F GLIDELIGHT IN USE IN THE AREA WHEN THE ENTRAPMENT AND PERFORATION OCCURRED, REQUIRING INTERVENTION.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24735858 ↗
• DeathMar 25, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA), TWO RIGHT VENTRICULAR (RV) LEADS, AND A LEFT VENTRICULAR (LV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ALL THE LEADS WERE REMOVED. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT; HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. A SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION PERFORATION WAS DISCOVERED, BUT REPAIR ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT DID NOT SURVIVE THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT USED IN THE PROCEDURE WHEN A PERFORATION OCCURRED, REQUIRING INTERVENTION, BUT RESULTING IN DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 24690347 ↗
• MalfunctionMar 24, 2026Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE LEADS WERE HEAVILY ADHERED, AND DURING REPEATED ADVANCEMENT AND RETRACTION, LASER LIGHT WAS OBSERVED EXITING LATERALLY FROM THE CATHETER TIP (MDR #3007284006-2026-00028). THEREFORE, A SECOND GLIDELIGHT LASER SHEATH WAS UTILIZED TO REMOVE THE LEADS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE SECOND GLIDELIGHT WAS NOT REPORTED BY THE FACILITY, BUT WAS RETURNED FOR EVALUATION ON 17MAR2026. VISUAL INSPECTION FOUND A BREACH TO THE OUTER JACKET JUST DISTAL TO THE BIFURCATE HANDLE WITH BROKEN FIBERS AND MELTING OBSERVED (MDR #). ADDITIONALLY, HEAVY BIOLOGICS WERE PRESENT AT THE DISTAL TIP . THIS EVENT IS BEING REPORTED FOR THE SECOND GLIDELIGHT DUE TO UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 24680536 ↗

Other Spectranetics Corporation products

• LLD EZ Lead Locking Device2 models · 345 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