HeartSpan® 00884450286449Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450286449), received between Apr 14, 2021 and Apr 14, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AN A-FIB ABLATION PROCEDURE, WHILE PERFORMING A TRANSSEPTAL PUNCTURE THERE WAS DIFFICULTY VISUALIZING THROUGH THE TEE PROBE. THE PHYSICIAN MENTIONED THAT THE LEFT AND RIGHT ATRIUM WHERE DIFFERENTLY ORIENTATED THAN IN A NORMAL ANATOMY AND THE SEPTUM WAS TURNED TO A MORE POSTERIOR POSITION. THE FIRST TRANSSEPTAL PUNCTURE WAS SUCCESSFULLY COMPLETED WITH THE PREFACE SHEATH AND HEARTSPAN NEEDLE. NORMAL PRESSURES NOTED FROM WITHIN THE LEFT ATRIUM. THEN A SECONDARY PUNCTURE FOR A SECOND SHEATH, ONLY A FEW MILLIMETERS MORE POSTERIOR WAS ATTEMPTED. IT WAS NOT POSSIBLE TO SEE THE TIP OF THE NEEDLE ON ECHO [TENTING] DURING TRANSSEPTAL PUNCTURE. IT WAS NOTED THAT POST-SECOND HEARTSPAN NEEDLE/SHEATH PUNCTURE, THAT NO BLOOD WAS RETURNING, ONLY TRANSPARENT FLUID. VERY LOW PRESSURES WERE NOTED WITHIN THE PATIENT. AFTER GUIDE WIRE INSERTION, IT WAS CLEAR THAT THE SHEATH WAS INADVERTENTLY PLACED WITHIN THE EPICARDIAL SPACE. THIS WAS CONFIRMED BY ECHO. PATIENT REMAINED STABLE, NO HEMODYNAMIC CHANGES TO REPORT. PERICARDIAL EFFUSION WAS NOTED AND APPROXIMATELY 60ML'S OF FLUID WAS RETRACTED FROM THE PERICARDIAL SPACE. THE PATIENT HAD 2500 UNITS OF HEPARIN BEFORE PUNCT

  Patient problems: Pericardial Effusion

  MAUDE report 11667583 ↗