HeartSpan® 00884450160923Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450160923), received between Aug 31, 2021 and Oct 6, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTS THAT DURING AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED. AFTER GOING TRANSSEPTAL CATHETER DEVICE WAS INSERTED INTO THE BODY AS THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. PERICARDIAL EFFUSION WAS CONFIRMED BY ICE WHEN VIEWING THE VENTRICULAR REGION. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 200 CC OF FLUID WAS REMOVED. IT WAS CONFIRMED THAT THE ABLATION CATHETER WAS NOT IN THE BODY AND THE TRANSSEPTAL CATHETER WAS NOT YET PLUGGED IN DURING TRANSSEPTAL. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 12585729 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER ALLEGES THAT DURING THE TRANSEPTAL PUNCTURE, THE PROVIDER NOTICED A SMALL PERICARDIAL EFFUSION AFTER FEW ATTEMPTS TO MAKE THE TRANSEPTAL CROSS. AS SOON THE PHYSICIAN REVIEWED THE TEE, TO ENSURE THE PATIENT SAFETY, HE DECIDED TO CANCEL THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARDIAC UNIT FOR CLOSE MONITORING WITH OUT ANY OTHER ISSUE AND IN GOOD CONDITION.

  Patient problems: Pericardial Effusion

  MAUDE report 12576876 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTS THAT DURING A WATCHMAN IMPLANT, THE PHYSICIAN NOTICED A SMALL PERICARDIAL EFFUSION AFTER FEW ATTEMPTS TO MAKE THE TRANSEPTAL CROSS. THE PHYSICIAN DECIDED TO CANCEL THE PROCEDURE FOR PATIENT SAFETY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARDIAC UNIT FOR CLOSE MONITORING. THERE WERE NO OTHER ISSUES AND THE PATIENT IS IN GOOD CONDITION.

  Patient problems: Pericardial Effusion

  MAUDE report 12397132 ↗