HeartSpan® 00884450489345Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450489345), received between Oct 26, 2021 and Nov 25, 2025 — classified as 1 death, 1 injury.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 19, 2021Terminated

   The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.

   Z-1262-2021 · Root cause: Process control · Recall details · FDA record ↗

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.

• DeathNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE FOR PULMONARY VEIN ISOLATION (PVI), A PERICARDIAL EFFUSION OCCURRED AND THE PATIENT EXPIRED. THE DIAGNOSTIC CATHETERS WERE PLACED IN THE BUNDLE OF HIS AND RIGHT ATRIUM CORONARY SINUS POSITION AND TRANSSEPTAL PUNCTURE WAS DONE SUCCESSFULLY. AFTERWARDS THE MAPPING CATHETER WAS PLACED IN THE LEFT ATRIUM AND STEERING WAS NOTED TO BE DIFFICULT. A CARDIAC ULTRASOUND SHOWED A PERICARDIAL EFFUSION IN THE PATIENT. A PERICARDIOCENTESIS WAS THEN PERFORMED. DURING THE NEXT HOUR APPROXIMATELY 1.5 LITERS BLOOD WERE WITHDRAWN FROM THE PERICARDIUM. THE EMERGENCY TEAM ENTERED THE ROOM AND SOON THE PATIENT SHOWED ASYSTOLE. THE EMERGENCY TEAM BEGAN WITH CPR, HOWEVER THE PATIENT DID NOT RECOVER AND EXPIRED IN THE CATH LAB. THE PHYSICIAN STATED THAT THERE WERE NO PRODUCT PERFORMANCE ISSUES WITH ANY ABBOTT PRODUCTS USED IN THIS CASE. ACCORDING TO THE PHYSICIAN THE CAUSE OF THE EFFUSION AND OF THE PATIENT'S DEATH ARE NOT CLEARLY KNOWN BUT THAT THE PERFORATION COULD HAVE POTENTIALLY OCCURRED AFTER TRANSSEPTAL PUNCTURE ON THE LEFT ATRIUM ROOF.

  Patient problems: Asystole; Cardiac Arrest; Cardiac Perforation; Pericardial Effusion

  MAUDE report 23645273 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST PULMONARY VEIN ISOLATION THE PATIENT WAS HYPOTENSIVE. APPROXIMATELY ONE HOUR POST PROCEDURE THE PATIENT CONTINUED TO BE HYPOTENSIVE AND APPEARED TO BE IN TAMPONADE. THE TRANSSEPTAL PUNCTURE WAS DIFFICULT, PERFORMED WITH TEE. NO ABLATION WAS MADE ON THE LEFT POSTERIOR WALL.

  Patient problems: Cardiac Tamponade

  MAUDE report 12700211 ↗