HeartSpan® 00884450412862Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450412862), received between Jun 8, 2021 and Aug 17, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE SHEATH WAS DIFFICULT TO FLUSH AND DRAW BACK THROUGH THE FLUSH PORT. THE SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THE ACCOUNT STATED THAT THEY HAD DONE THE TRANSSEPTAL AND HAD MAPPED THE LEFT ATRIUM WHEN ANESTHESIOLOGY REPORTED THAT THE PATIENT'S BLOOD PRESSURE HAD DROPPED. A PERICARDIAL PERFUSION WAS CONFIRMED USING ICE. THE PROCEDURE WAS ABORTED AND THE EFFUSION WAS BEING MONITORED. NO INTERVENTION WAS PLANNED. PATIENT WAS STABLE. NO ABLATIONS HAD BEEN PERFORMED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 12333500 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT AFTER USE OF THE MERIT HEARTSPAN TRANSSEPTAL NEEDLE, PATIENT BEGAN TO DECOMPENSATE DUE TO CARDIAC TAMPONADE CONFIRMED WITH THORACIC ECHOGRAPHY. PATIENT WAS TAKEN TO CARDIAC SURGERY WHERE A HOLE BETWEEN THE SVC AND RA WAS SUCCESSFULLY CLOSED.

  Patient problems: Cardiac Tamponade; Needle Stick/Puncture

  MAUDE report 11962111 ↗