HeartSpan® 00884450489437Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450489437), received between Jul 28, 2021 and Mar 5, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT AFTER A TRANSEPTAL PUNCTURE TECHNIQUE DURING AN A-FIB ABLATION PROCEDURE, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION WITH POOR HEMODYNAMIC PRESSURE. A PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED TO DRAIN THE FLUID. THE PHYSICIAN IS NOT SURE WHAT CAUSED THE EFFUSION FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842869 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST-PVI ABLATION PROCEDURE THE PATIENT SUFFERED A CARDIAC TAMPONADE EVENT. THERE WERE NO SIGNS OF EFFUSION OR INJURY DURING THE ACTUAL PROCEDURE. THE PHYSICIAN STATES THAT THE PERFORATION LIKELY OCCURRED DURING THE SECOND TRANSEPTAL PUNCTURE ATTEMPT DUE TO THE ANGLE OF THE TARGETED SEPTUM. THE PATIENT'S HEART RATE DID INCREASE DURING THE ABLATION PROCEDURE WHICH WAS SUCCESSFULLY MANAGED BY THE ATTENDING ANESTHESIOLOGIST. THE PATIENT ALSO REQUIRED A BLOOD TRANSFUSION POST-PROCEDURE AND BECAME STABLE AFTER THE NECESSARY INTERVENTIONAL TREATMENTS. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552410 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING THE ABLATION PHASE OF A PROCEDURE, THE PATIENT DEVELOPED ATRIAL TACHYCARDIA AND HYPOTENSION. AN ECHOCARDIOGRAM WAS PERFORMED AND FOUND THE MYOCARDIAL TISSUE HAD BEEN PERFORATED AND PERICARDIAL EFFUSION. THE PERFORATION WAS SEALED AND THE PROCEDURE CONTINUED. ANOTHER EFFUSION DEVELOPED AND THE PROCEDURE DISCONTINUED. ONLY THE LEFT PULMONARY VEINS WERE ISOLATED DURING THE PROCEDURE. THE PATIENT HAS NOT SUFFERED CONSEQUENCES DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675234 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE ACCOUNT ALLEGES THAT DURING AN A-FIB PROCEDURE, WHILE UNDER GENERAL ANESTHESIA, DURING THE MAPPING PHASE, THE ANESTHESIOLOGISTS NOTICED A DEPRECIATION OF THE VITAL PARAMETERS, SUCH AS BLOOD PRESSURE DROP. THE TRANSESOPHAGEAL ECHO SHOWED FLUID IN THE PERICARDIUM, THUS A PERICARDIOCENTESIS WAS PERFORMED FOR DRAINING THE BLOOD. AS THE FLUID DRAINED, IT WAS CONCLUDED THAT OPEN CHEST SURGERY WAS NEEDED FOR THE BLEEDING TO BE STOPPED. THE PATIENT WAS TRANSFERRED TO THE OR AND THE SURGEONS FOUND A PERFORATION IN THE LEFT ATRIAL APPENDAGE (LAA). THE PATIENT WAS TRANSFERRED TO THE ICU POST-OP. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 13656743 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AN ATRIAL FIBRILLATION CASE, A PERICARDIAL EFFUSION WAS NOTICED. IT IS THOUGHT THAT THE HEARTSPAN TRANSSEPTAL NEEDLE EITHER "NICKED" THE AORTA OR THE ROOF OF THE LEFT ATRIUM. AFTER ISOLATING THREE OF THE PULMONARY VEINS, THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE AND ECHO. MEDICAL INTERVENTION WAS A PERICARDIOCENTESIS PROCEDURE WITH 1.5 L OF FLUID BEING REMOVED. "KCENTRA" PROTHROMBIN WAS INJECTED THROUGH THE CENTRAL IV LINE AND "FLOSEAL" THROMBIN GEL FOAM WAS ALSO INJECTED INTO THE PATIENT'S PERICARDIAL SAC. AFTER ABOUT 30 MINUTES, ANOTHER TRANSTHORACIC ECHO WAS PERFORMED FOR CONFIRMATION AND THE PATIENT WAS THEN TAKEN INTO ICU FOR FURTHER MONITORING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO FURTHER PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Cardiac Tamponade

  MAUDE report 12239771 ↗