HeartSpan® 00884450169704Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450169704), received between Jan 10, 2020 and Feb 24, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AN ATRIAL FIBRILLATION RADIO FREQUENCY ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE PATIENT REMAINED ASYMPTOMATIC, HOWEVER, AN ICE CATHETER REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PERICARDIUM WAS DRAINED OF FLUID. PATIENT REMAINED STABLE AND WAS MONITORED OVERNIGHT. THE HEALTHCARE SPECIALIST BELIEVES THAT THE ADVERSE HEALTH CONSEQUENCES WERE UNRELATED TO PRODUCT PERFORMANCE.

  Patient problems: Pericardial Effusion

  MAUDE report 11373604 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A TRANSSEPTAL PUNCTURE THE NEEDLE PUNCTURED THE EPICARDIUM. THE PROCEDURE WAS CANCELLED.

  Patient problems: Cardiac Perforation

  MAUDE report 9857537 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A TRANSSEPTAL PUNCTURE A NEEDLE WAS USED TO PUNCTURE THE SEPTUM. THE PHYSICIAN NOTED UNDER FLUOROSCOPY, THAT A PERICARDIAL PUNCTURE HAD OCCURRED. THE PROCEDURE WAS THEN TERMINATED, AND AN ECHOCARDIOGRAM PERFORMED. THE PERICARDIAL EFFUSION COULD NOT BE IDENTIFIED OR DOCUMENTED. THE PATIENT REMAINED STABLE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT [ICU] FOR FURTHER OBSERVATION.

  Patient problems: Cardiac Perforation

  MAUDE report 9826406 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A PVI ABLATION PROCEDURE, A HEARTSPAN SHEATH AND NEEDLE WERE USED FOR TRASSEPTAL PUNCTURE. DURING MAPPING OF THE LEFT ATRIUM, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS DROPPING. A PERICARDIAL EFFUSION WAS NOTED AND THE CASE WAS ABORTED. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS, BUT THE PATIENT'S CONDITION DID NOT STABILIZE. A SURGEON THEN PERFORMED A PERICARDIAL WINDOW TO FIND THE PERFORATION AND WAS UNSUCCESSFUL. A STERNAL INCISION WAS THEN PERFORMED WHERE A PERFORATION OF THE LEFT ATRIAL APPENDAGE WAS DISCOVERED AND SUCCESSFULLY CLOSED. THE PATIENT WAS RELEASED FROM THE HOSPITAL WITHOUT FURTHER INJURY REPORTED.

  Patient problems: Atrial Perforation

  MAUDE report 9577988 ↗