HeartSpan® 00884450263181Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450263181), received between Apr 17, 2020 and Jul 16, 2020 — 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE [LAAC] PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED ACCESS TO THE PATIENTS LEFT ATRIUM VIA TRANSSEPTAL PUNCTURE. A CLOSURE DEVICE WAS INTRODUCED INTO THE LEFT ATRIUM -A COUPLE OF TIMES- NEEDING RECAPTURE DUE TO A 5 MM GAP THAT WAS APPRECIATED. A 33 MM CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED WITHIN THE POSTERIOR LOBE WHEN A PERICARDIAL EFFUSION WAS NOTED. A FULL RECAPTURE OF THE CLOSURE DEVICE WAS COMPLETED. THE PATIENT WAS IN STABLE CONDITION, SO A NEW 33 MM CLOSURE DEVICE WAS IMPLANTED IN THE UPPER LOBE. AFTER FIRST RELEASE OF THE SECOND DEVICE, GOOD POSITIONING WAS OBSERVED. EVENTUALLY THE PATIENT'S VITAL SIGNS CHANGED INDICATING THAT CARDIAC MASSAGE AND PERICARDIOCENTESIS WAS NECESSARY. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO SURGERY DEPARTMENT.

  Patient problems: Pericardial Effusion

  MAUDE report 10283502 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A DIFFICULT TRANSSEPTAL PUNCTURE TO COMPLETE AN ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN HAD ACQUIRED ACCESS THROUGH THE FOSSA OVALIS AND INTO THE LEFT ATRIUM WITH A CORONARY SINUS CATHETER ATTEMPTING TO EFFECTIVELY MAP THE LEFT ATRIUM FOR THIS PATIENT. AFTER A FEW SECONDS OF USE, THE CATHETER WOULD NOT DEFLECT AS INTENDED. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. AFTER MAPPING THE LEFT ATRIUM, THE PATIENT BECAME HYPOTENSIVE. ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT AND THE PROCEDURE WAS DISCONTINUED. THE PHYSICIAN ALLEGED THE EFFUSION OCCURRED DURING THE TRANSSEPTAL PUNCTURE PROCEDURE. THE PHYSICIAN ATTEMPTED SEVERAL TIMES TO ACQUIRE ACCESS WITH THE NEEDLE WHICH RESULTED IN THE EFFUSION.

  Patient problems: Arrhythmia; Blood Loss; Cardiac Tamponade; Decreased Respiratory Rate; Low Cardiac Output; Non specific EKG/ECG Changes

  MAUDE report 9973603 ↗