HeartLight 18-3356Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00868976000147), received between Jul 15, 2019 and Sep 4, 2023 — classified as 20 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A PVI PROCEDURE WHERE A STEERABLE SHEATH WAS USED, THE PATIENT HAD A PERICARDIAL EFFUSION. THERE WAS NO DEVICE DEFICIENCY REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 17680506 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT AFTER A PVI PROCEDURE WHERE A STEERABLE SHEATH WAS USED, THE PATIENT HAD A MINOR STROKE. THERE WAS NO DEVICE DEFICIENCY REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 17595921 ↗
• InjuryMar 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILATION, AIR BUBBLES WERE NOTED IN THE LEFT ATRIUM BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AFTER THE ABLATION CATHETER HAD BEEN REPLACED WITH A LASSO CATHETER THROUGH THE SAME DEFLECTABLE SHEATH. AN ANGIOGRAM WAS PERFORMED AND THE AIR WAS MANUALLY ASPIRATED OUT OF THE LEFT ATRIUM. NO EFFECT ON THE PATIENT WAS REPORTED. WHILE NO INJURY OCCURRED AND NO DEVICE DEFICIENCY WAS REPORTED, THE REMOVAL OF THE AIR BY THE TREATING PHYSICIAN MAY HAVE PREVENTED AN INJURY FROM OCCURRING AND THIS MDR IS BEING REPORTED AS OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16603157 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE, THE PATIENT SUFFERED TRANSIENT HYPOXIA. NO REPORT OF DEFICIENCY WITH ANY OF THE DEVICES USED.

  Patient problems: Hypoxia

  MAUDE report 16493229 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE, THE PATIENT SUFFERED CARDIAC TAMPONADE. NO REPORT OF DEFICIENCY WITH ANY OF THE DEVICES USED.

  Patient problems: Cardiac Tamponade

  MAUDE report 16493227 ↗
• InjuryJan 20, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DURING A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION IN A PATIENT WITH SLEEP APNEA, THE PHYSICIAN NOTED THE PRESENCE OF AIR INSIDE THE RIGHT ATRIUM ON THE FLUOROSCOPIC IMAGE BEFORE THE ABLATION CATHETER WAS INTRODUCED. THE DEFLECTABLE SHEATH INTRODUCER FOR THE ABLATION PROCEDURE HAD BEEN INTRODUCED FOLLOWING A SWARTZ SL0 SHEATH AFTER THE TRANSSEPTAL PUNCTURE WAS MADE. THE PRESENCE OF THE AIR WAS CONFIRMED AFTER THE GUIDEWIRE AND DILATOR HAD BEEN REMOVED FROM THE DEFLECTABLE SHEATH INTRODUCER. THE SL0 SHEATH WAS MOVED INTO THE RIGHT ATRIUM AND THE AIR WAS REMOVED. HOWEVER, AIR ENTERED THE HEART AGAIN UPON THE PATIENT'S DEEP BREATHING. THE AIR WAS REMOVED AGAIN AND THE DEFLECTABLE INTRODUCER SHEATH WAS REPLACED AND THE PVI PROCEDURE COMPLETED. THERE WAS NO PATIENT ADVERSE EVENT. IT IS NOT KNOWN IF THE AIR ENTRY OCCURRED THROUGH THE DEFLECTABLE SHEATH INTRODUCER OR THE SL0 SHEATH. WHILE NO INJURY OCCURRED AND NO DEVICE DEFICIENCY WAS REPORTED, THE REMOVAL OF THE AIR BY THE TREATING PHYSICIAN MAY HAVE PREVENTED AN INJURY FROM OCCURRING AND THUS THIS MDR WILL REPORTED AS A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218952 ↗
• InjuryFeb 18, 2022Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, BLOOD PRESSURE BECAME UNSTABLE WHILE ABLATING THE RIGHT INFERIOR PULMONARY VEIN AFTER ABLATION OF THE LEFT-SIDED VEINS. ORDER OF VEIN TREATMENT WAS LEFT SUPERIOR, LEFT INFERIOR, RIGHT INFERIOR, AND RIGHT SUPERIOR. AFTER ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN IT WAS DETERMINED CARDIAC TAMPONADE HAD OCCURRED. CARDIAC DRAINAGE WAS IMMEDIATELY PERFORMED BUT ADDITIONAL TREATMENT WAS REQUIRED INCLUDING SURGICAL REPAIR. THE PERFORATION SITE WAS IDENTIFIED AS THE TIP OF THE LEFT ATRIAL APPENDAGE. APPROXIMATELY ONE WEEK POST PROCEDURE THE PATIENT WAS SHOWING SIGNS OF IMPROVEMENT.

  Patient problems: Cardiac Perforation

  MAUDE report 13560982 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, ST ELEVATION WAS NOTED BEFORE ABLATION BEGAN. CORONARY ANGIOGRAPHY SHOWED SLIGHT STENOSIS SO NITROGLYCERIN WAS ADMINISTERED, SLIGHTLY IMPROVING THE ST ELEVATION. THE PVI PROCEDURE WAS PERFORMED. NO AIR ENTRY OR THROMBUS WERE IDENTIFIED AND THE POSSIBILITY OF CORONARY SPASMS WAS NOT DENIED. THE CAUSE OF THE ST ELEVATION IS NOT KNOWN.

  Patient problems: Arrhythmia

  MAUDE report 12914203 ↗
• InjuryOct 8, 2021Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, A DROP IN BLOOD PRESSURE OCCURRED AND CARDIAC TAMPONADE WAS DIAGNOSED WITH ECHOCARDIOGRAPHY. THE CARDIAC TAMPONADE WAS SUCCESSFULLY TREATED BY PERICARDIOCENTESIS. THE PHYSICIAN BELIEVES THE CAUSE OF THE CARDIAC TAMPONADE WAS AN ELECTROPHYSIOLOGY CATHETER AND SHEATH, MADE BY A DIFFERENT MANUFACTURER, WHICH WERE USED TO CHECK FOR POTENTIALS IN THE RIGHT SUPERIOR PULMONARY VEIN. HOWEVER, THE PHYSICIAN COULD NOT EXCLUDE THE DEFLECTABLE SHEATH AS A POSSIBLE CAUSE OF THE CARDIAC TAMPONADE.

  Patient problems: Cardiac Perforation

  MAUDE report 12601476 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER A SUCCESSFUL PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, TENDERNESS IN RIGHT GROIN AREA WAS REPORTED THE MORNING AFTER THE PROCEDURE. ARTERIAL DUPLEX DOPPLER REVEALED A 3 CM PSEUDOANEURYSM ARISING FROM THE RIGHT COMMON FEMORAL ARTERY. INTERVENTIONAL RADIOLOGY WAS USED TO INJECT HEPARIN AND HOSPITALIZATION WAS EXTENDED BY ONE DAY. THE PATIENT STATUS IS BEING MONITORED.

  Patient problems: Pseudoaneurysm

  MAUDE report 11555957 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, TRANSIENT ST SEGMENT ELEVATION WAS NOTED. THE TREATING PHYSICIAN ATTRIBUTED THE ST SEGMENT ELEVATION TO AIR ENTRY THROUGH THE DEFLECTABLE SHEATH. AN UNKNOWN MEDICATION WAS ADMINISTERED, THE ST SEGMENT ELEVATION RESOLVED, AND THE PVI PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED WITHOUT ANY SYMPTOMS OR SEQUELAE.

  Patient problems: Air Embolism

  MAUDE report 11026943 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, ST SEGMENT ELEVATION WAS NOTED WHEN THE ABLATION CATHETER WAS INSERTED. CORONARY ANGIOGRAPHY DID NOT CONFIRM AN AIR EMBOLISM BUT THE POSSIBILITY OF CORONARY SPASMS WAS SUGGESTED. MEDICATION WAS ADMINISTERED AND THE ST SEGMENT ELEVATION WAS NO LONGER OBSERVED. ECHOCARDIOGRAPHY FOUND NO ABNORMALITY IN THE MOTION OF THE ATRIAL WALL, SUGGESTING THERE WAS NO DAMAGE TO THE CARDIAC MUSCLE. REVIEW OF THE PROCEDURAL DATA CONFIRMED THE ST SEGMENT ELEVATION OCCURRED PRIOR TO THE INTRODUCTION OF THE ABLATION CATHETER. THE PATIENT EXHIBITED NO POST-PROCEDURAL EFFECTS FROM THE EVENT. IN ADDITION TO THE ABLATION SHEATH, THREE DIFFERENT CATHETERS FROM OTHER MANUFACTURERS WERE USED TO TREAT THIS PATIENT. TWO DIFFERENT DIAGNOSTIC CATHETERS WERE USED, WITH THE CATHETER EXCHANGES OCCURRING BEFORE THE ST SEGMENT ELEVATION OCCURRED. IT WAS ALSO REPORTED THAT IT TOOK NEARLY AN HOUR TO INTRODUCE A THIRD CATHETER INTO THE CORONARY SINUS, AGAIN PRIOR TO THE EVENT. HOWEVER, THE TREATING PHYSICIAN COULD NOT CONCLUSIVELY DETERMINE THE CAUSE OF THE ST SEGMENT ELEVATION. BECAUSE THE SHEATH CANNOT BE RULED OUT AS A CAUSE, THIS MDR IS

  Patient problems: Air Embolism

  MAUDE report 10587984 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, CARDIAC TAMPONADE OCCURRED PRIOR TO ABLATION. PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY SUCCESSFUL CARDIAC SURGERY.

  Patient problems: Cardiac Perforation

  MAUDE report 10508555 ↗
• InjuryMar 13, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING A PULMONARY VEIN ISOLATION (PVI) TO TREAT ATRIAL FIBRILLATION THE LEFT ATRIAL APPENDAGE WAS PERFORATED BY THE INTRODUCER SHEATH. THE PERFORATION WAS SURGICALLY REPAIRED AND THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Cardiac Perforation

  MAUDE report 9831935 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, SHEATH EXCHANGE WAS PERFORMED AND THE DILATOR FOR THE ABLATION CATHETER INTRODUCER SHEATH WAS REMOVED FROM THE SHEATH. SHORTLY AFTER THE SHEATH EXCHANGE A DROP IN BLOOD PRESSURE AND ST SEGMENT ELEVATION ON ECG WERE NOTED. AIR BUBBLES WERE VISUALLY CONFIRMED IN THE AORTIC ARCH AND RIGHT CORONARY ARTERY, CONFIRMING AIR EMBOLISM. ATTEMPTS TO ASPIRATE THE AIR BUBBLES WERE NOT SUCCESSFUL. BLOOD PRESSURE RECOVERED AFTER ABOUT 15-20 MINUTES AND THE PROCEDURE WAS STOPPED. POST-PROCEDURAL CT SCAN SHOWED NO EVIDENCE OF INJURY.

  Patient problems: Air Embolism

  MAUDE report 9772094 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVANCE LITERATURE PUBLICATION REPORTED A VASCULAR ACCESS COMPLICATION IN A PULMONARY VEIN ISOLATION (PVI) PROCEDURE. THE PATIENT DEVELOPED A SEVERE GROIN HEMATOMA, WHICH WAS TREATED BY BLOOD TRANSFUSION. NO SURGICAL INTERVENTION WAS NECESSARY. NO PRODUCT INFORMATION WAS PROVIDED AND NO DEVICE DEFICIENCY REPORTED. THE VASCULAR ACCESS COMPLICATION WAS REPORTED AS NOT DIRECTLY RELATED TO THE MANUFACTURER'S DEVICE.

  Patient problems: Hematoma

  MAUDE report 9434434 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION WAS PERFORMED ON (B)(6) 2018. DURING 3-MONTH POSTOPERATIVE FOLLOW-UP IT WAS LEARNED THE PATIENT HAD RECEIVED AN OPERATION TO TREAT A THROMBOTIC VENOUS ANEURYSM AND THE PATIENT HAD ALREADY RECOVERED. DATE OF ONSET OF THE ADVERSE EVENT WAS NOT REPORTED. THE OPERATION TO TREAT THE THROMBOTIC VENOUS ANEURYSM WAS NOT PERFORMED BY THE PHYSICIAN PERFORMING THE 3-MONTH POSTOPERATIVE FOLLOW-UP AND DETAILS OF THE OPERATION, MEDICAL CONDITION, OR TREATMENT PERFORMED ARE UNKNOWN. IT WAS REPORTED THE SITE OF THE INJURY WAS RELATED TO THE PUNCTURE SITE OF THE PVI PROCEDURE, ALTHOUGH THE SIDE OF THE PATIENT WITH THE INJURY WAS NOT REPORTED SO CAUSALITY WITH THE DEFLECTABLE SHEATH CANNOT BE DETERMINED.

  Patient problems: Pseudoaneurysm

  MAUDE report 9330856 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DIAGNOSED WITH MINOR CEREBRAL AIR EMBOLISM DAY AFTER A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION. THE PVI PROCEDURE WAS PERFORMED IN NORMAL FASHION. PATIENT WAS TO BE DISCHARGED FROM THE HOSPITAL WHEN PATIENT REPORTED HAVING BLURRED/DOUBLE VISION. AN MRI WAS PERFORMED AND NEUROLOGIST DIAGNOSED MINOR CEREBRAL AIR EMBOLISM. THE PATIENT'S DISCHARGE WAS DELAYED ONE DAY. THE PATIENT'S VISION HAD RETURNED TO NORMAL PRIOR TO DISCHARGE FROM THE HOSPITAL. THE CAUSE OF THE AIR EMBOLISM COULD NOT BE DETERMINED BUT THE HEARTLIGHT SHEATH CANNOT BE EXCLUDED.

  Patient problems: Infarction, Cerebral

  MAUDE report 8897345 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE BEGINNING OF A PULMONARY VEIN ISOLATION (PVI) PROCEDURE, THE CATHETER WAS INADVERTENTLY ADVANCED INTO THE LEFT ATRIAL APPENDAGE TWICE. THE CATHETER WAS MOVED TOWARD THE LEFT SUPERIOR PULMONARY VEIN (LSPV). AFTER 5 MINUTES THE PATIENT'S BLOOD PRESSURE DECREASED AND PERICARDIAL EFFUSION WAS DIAGNOSED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PERICARDIAL EFFUSION WAS DRAINED THROUGH PERICARDIOCENTESIS AND BLOOD TRANSFUSION WAS PERFORMED. AFTER CONFIRMING THE PATIENT'S BLOOD PRESSURE WAS STABLE AND THERE WAS NO INCREASE IN THE PERICARDIAL EFFUSION, THE PROCEDURE WAS STOPPED WITH NO ABLATION PERFORMED.

  Patient problems: Cardiac Tamponade; Patient Problem/Medical Problem

  MAUDE report 8796047 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE THE PATIENT DEVELOPED A PERICARDIAL EFFUSION REQUIRING A PERICARDIAL WINDOW FOR DRAINAGE. IT COULD NOT BE CONFIRMED HOW THE EFFUSION FORMED. A PERICARDIAL WINDOW WAS PERFORMED AND A DRAIN WAS PLACED. IT WAS REPORTED THE PATIENT WAS "DOING FINE" THE FOLLOWING DAY.

  Patient problems: Cardiac Tamponade; Patient Problem/Medical Problem

  MAUDE report 8791597 ↗