HeartLight 18-4000-27ARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00868976000178), received between Sep 10, 2018 and Dec 8, 2020 — classified as 1 death, 15 injuries.

1 other recall cover devices cleared under the same FDA submission (P150026); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 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 WHILE ABLATING THE LEFT SUPERIOR PULMONARY VEIN. AFTER VERIFICATION OF THE TAMPONADE WITH ULTRASOUND, PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY CARDIAC SURGERY.

  Patient problems: Cardiac Perforation

  MAUDE report 10972727 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PULMONARY VEIN ISOLATION (PVI) PROCEDURE WAS PERFORMED ON (B)(6) 2020 WITHOUT INCIDENT. HIGH OUTPUT PACING OF THE PHRENIC NERVE WAS PERFORMED AND THERE WAS NO LOSS OF CAPTURE DURING THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 WITH DECREASED LUNG VOLUME AND RELEASED ON (B)(6) 2020 WITH IMPROVED LUNG VOLUME. THE TREATING PHYSICIAN CONCLUDED THE DECREASED LUNG VOLUME WAS MOST LIKELY DUE TO A PHRENIC NERVE INJURY, DESPITE THERE BEING NO PRESENTATION OF INJURY DURING THE PROCEDURE. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Nerve Damage; Patient Problem/Medical Problem

  MAUDE report 9793614 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE A PERICARDIAL EFFUSION WAS OBSERVED WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE PERICARDIAL EFFUSION WAS DRAINED WITHOUT ISSUE AND THE TREATING PHYSICIAN REPORTED THE PATIENT WAS IN GOOD CONDITION THE MORNING FOLLOWING THE PROCEDURE. THE CASE WAS STOPPED AFTER THE PERICARDIAL EFFUSION WAS NOTED, AFTER TREATMENT OF THE LEFT SIDED PULMONARY VEINS AND APPROXIMATELY 2/3 OF THE RSPV. THE MEDICAL TEAM WAS NOT ABLE TO DETERMINE THE CAUSE OF THE PERICARDIAL EFFUSION.

  Patient problems: Patient Problem/Medical Problem; Pericardial Effusion

  MAUDE report 9701776 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVANCE LITERATURE PUBLICATION REPORTED A PERIPROCEDURAL TRANSIENT ISCHEMIC ATTACK OF UNKNOWN SOURCE DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE. THE SYMPTOMS COMPLETELY RESOLVED DURING THE HOSPITAL STAY. NO PRODUCT INFORMATION WAS PROVIDED AND NO DEVICE DEFICIENCY REPORTED.

  Patient problems: Transient Ischemic Attack

  MAUDE report 9434432 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE, LOSS OF PHRENIC NERVE CAPTURE WAS OBSERVED THROUGH COMPOUND MUSCLE ACTION POTENTIAL (CMAP) MONITORING WHILE TREATING THE RIGHT SUPERIOR PULMONARY VEIN. USING FLUOROSCOPY THE PATIENT'S DIAPHRAGM WAS OBSERVED TO HAVE SLIGHTLY RISEN BUT ITS MOVEMENT HAD NOT COMPLETELY STOPPED. THE PATIENT WAS ASYMPTOMATIC THROUGHOUT.

  Patient problems: Nerve Damage; Patient Problem/Medical Problem

  MAUDE report 9347374 ↗
• InjuryNov 1, 2019Adverse 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 THE CATHETER AND SHEATH WERE NOTICED TO BE IN THE LEFT ATRIAL APPENDAGE (LAA). ALMOST IMMEDIATELY AFTER MOVING TO THE LEFT SUPERIOR PULMONARY VEIN A PERICARDIAL EFFUSION WAS OBSERVED ON INTRACARDIAC ECHOCARDIOGRAM. THE EFFUSION QUICKLY DEVELOPED INTO CARDIAC TAMPONADE AND THE PATIENT CONDITION WORSENED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR FURTHER EVACUATION OF THE TAMPONADE. PERFORATION OF THE LAA WAS CONFIRMED AND THE LAA WAS REPAIRED INTRA-OPERATIVELY.

  Patient problems: Cardiac Tamponade; Patient Problem/Medical Problem

  MAUDE report 9269382 ↗
• 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 CATHETER CANNOT BE EXCLUDED.

  Patient problems: Infarction, Cerebral

  MAUDE report 8897335 ↗
• 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 8791595 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PVI PROCEDURE WAS PERFORMED (B)(6) 2019. DURING ABLATION OF THE RSPV, TRANSIENT LOSS OF DIAPHRAGMATIC STIMULATION WAS NOTED, BUT BY THE END OF THE CASE, PHRENIC NERVE APPEARED TO BE INTACT BASED ON SNIFF TEST. SOMETIME AFTER THE PROCEDURE THE PATIENT CALLED THE PHYSICIAN'S OFFICE WITH COMPLAINTS OF SHORTNESS OF BREATH, DIFFICULTY SWALLOWING, AND FLEETING CHEST PAIN, AND WAS ADVISED TO GO TO ED. IN ED, CHEST X-RAY REVEALED ELEVATED RIGHT HEMIDIAPHRAGM. ED RULED OUT ACUTE PROCESS AND PATIENT WAS DISCHARGED TO HOME. ECHO PROCEDURE WAS PERFORMED ON (B)(6) 2019 AND RESULTS WERE GROSSLY WITHIN NORMAL LIMITS. SNIFF TEST WAS PERFORMED ON (B)(6) 2019 AND REVEALED CLEAR DIAPHRAGMATIC PARALYSIS.

  Patient problems: Nerve Damage; Patient Problem/Medical Problem

  MAUDE report 8745796 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE PERFORMING AN INITIAL PVI, THE PATIENT WAS NOTED TO HAVE INCREASING PERICARDIAL EFFUSION USING INTRACARDIAC ECHOCARDIOGRAM (ICE). THE PROCEDURE WAS STOPPED AFTER ABLATING THE LSPV AND APPROXIMATELY 75% OF THE LIPV. DURING INITIAL ATTEMPT TO ACCESS THE LEFT SUPERIOR PULMONARY VEIN (LSPV) THE CATHETER APPEARED TO BE IN THE LEFT ATRIAL APPENDAGE (LAA) INSTEAD OF THE LSPV. THE CATHETER BALLOON WAS INFLATED AND THE CATHETER WAS CONFIRMED TO BE IN THE LAA. THE CATHETER BALLOON WAS DEFLATED, THE CATHETER WAS REPOSITIONED, AND THE LSPV WAS ABLATED. THE CATHETER WAS MOVED TO THE LEFT INFERIOR PULMONARY VEIN (LIPV) WHEN IT WAS NOTED THE EFFUSION CONTINUED TO INCREASE. THE PHYSICIAN STOPPED THE ABLATION PROCEDURE AND PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED.

  Patient problems: Cardiac Tamponade; Patient Problem/Medical Problem

  MAUDE report 8671945 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN ELECTED TO TRY AND ISOLATE THE SUPERIOR VENA CAVA. DURING AN ENERGY DELIVERY CAPTURE OF THE PHRENIC NERVE WAS LOST AND ENERGY DELIVERY WAS STOPPED. CASE DATE WAS (B)(6) 2019. UPDATE RECEIVED ON (B)(6) 2019 CONFIRMED THE PATIENT WAS DOING WELL CLINICALLY BUT THE PHRENIC NERVE WAS STILL PARALYZED ON EXAM.

  Patient problems: Nerve Damage; Patient Problem/Medical Problem

  MAUDE report 8596436 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH HEARTLIGHT SYSTEM ON (B)(6) 2019. MANUFACTURER REPRESENTATIVE WAS INFORMED DAY AFTER ABLATION PROCEDURE (APRIL 12, 2019) THAT THE PATIENT HAD A STROKE, SEVERITY UNKNOWN. NO DEVICE DEFICIENCIES REPORTED AND PHYSICIANS INVOLVED EXPRESSED DOUBT HEARTLIGHT SYSTEM WAS CAUSE OF STROKE. HOWEVER, RELATIONSHIP BETWEEN THE STROKE AND ADVERSE EVENT CANNOT BE EXCLUDED. IN ADDITION TO STROKE, THE MANUFACTURER REPRESENTATIVE WAS INFORMED PATIENT WAS HAVING GROIN ISSUES POST-PROCEDURE, SEVERITY UNKNOWN.

  Patient problems: Infarction, Cerebral

  MAUDE report 8594918 ↗
• DeathApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH HEARTLIGHT SYSTEM ON (B)(6) 2019. PATIENT HAD A LEFT COMMON PULMONARY VEIN (LCPV). ESOPHAGEAL TEMPERATURE RISES WERE EXPERIENCED WHEN ABLATING ALONG THE POSTERIOR WALL OF THE LCPV. NUMEROUS LOCATIONS ALONG THE POSTERIOR WALL WERE ABLATED WHERE TEMPERATURE RISES WERE OBSERVED. ABLATION WAS DISCONTINUED WHEN OBSERVED ESOPHAGUS TEMPERATURE EXCEEDED 38.5° C, RESULTING IN SHORT ENERGY DELIVERIES. THE LCPV WAS NOT ISOLATED. THE HEARTLIGHT CATHETER WAS REMOVED AND THE POSTERIOR WALL OF THE SAME VEIN WAS TREATED WITH 2-3 FULL FREEZES USING CRYOCATH. ON (B)(6) 2019 THE PATIENT REPORTED FEVER AND NEUROLOGICAL SYMPTOMS. ATRIO-ESOPHAGEAL FISTULA WAS CONFIRMED, WHICH LED TO PATIENT DEATH.

  Patient problems: Death; Perforation of Esophagus

  MAUDE report 8495760 ↗
• InjuryNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABLATION WAS DONE ON (B)(6) 2018 AND ON (B)(6) 2018 THE PATIENT RETURNED WITH CHEST PAIN. PATIENT WAS DIAGNOSED WITH ESOPHAGEAL ULCER AND WAS TREATED MEDICALLY AND DISCHARGED ON (B)(6) 2018. PATIENT WAS BACK TO BASELINE AT FOLLOW-UP VISIT ON (B)(6) 2018.

  Patient problems: Laceration(s) of Esophagus; Patient Problem/Medical Problem

  MAUDE report 8103541 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRANSSEPTAL ACCESS WAS DONE AND LSPV WAS ISOLATED. DURING LIPV ISOLATION PATIENT BLOOD PRESSURE DECREASED AND PERICARDIAL EFFUSION WAS NOTED. NO DEFICIENCIES WITH ANY CARDIOFOCUS DEVICE WERE REPORTED.

  Patient problems: Pericardial Effusion

  MAUDE report 7886549 ↗
• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHRENIC NERVE DAMAGE LEADING TO DIAPHRAGMATIC PARALYSIS.

  Patient problems: Nerve Damage

  MAUDE report 7861090 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150026. One submission often covers many models, so check the product and lot details in each record.

• Z-1307-2025 · Feb 7, 2025 · Open, Classified
  CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Labor