POLARSHEATH™ M004CRBS3150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506039776), received between Oct 2, 2023 and Oct 15, 2025 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING AT THE RIGHT GROIN SITE. ON (B)(6) 2025, THE PATIENT UNDERWENT ATRIAL FLUTTER (AFL) ABLATION AS PART OF THE POLARX PAS CLINICAL TRIAL. ON (B)(6) 2025, WHILE IN THE RECOVERY ROOM FOR A FEW HOURS, THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING AT THE RIGHT GROIN SITE. A FEMSTOP DEVICE WAS PLACED, FOLLOWED BY A PRESSURE DRESSING. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DID NOT SHOW ANY ACTIVE BLEEDING OR PSEUDOANEURYSM. BY THE FOLLOWING DAY, THE PATIENT SHOWED SIGNIFICANT IMPROVEMENT ON EXAMINATION. THE RIGHT GROIN SITE WAS SOFT, WITH ONLY MILD BRUISING NOTED. THE PATIENT REMAINS UNDER OBSERVATION. ON (B)(6) 2025, DIAGNOSTIC TESTS WERE CONDUCTED IN RELATION TO THE PATIENT'S ADVERSE EVENT. THE ISSUE WAS RESOLVED ON (B)(6) 2025. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISPOSED OF BY THE FACILITY. IT WAS FURTHER REPORTED THAT THE HEMOGLOBIN AND HEMATOCRIT LEVELS REMAINED STABLE WITHOUT THE NEED FOR ANY RBC TRANSFUSIONS. CONTRAST CT AORTOGRAM ON (B)(6) 2025 REVEALED RIGHT GROIN INSTRUMENTATION CHANGES WITHOUT ACTIVE HEMORRHAGE OR PSEUDOANEURYSM, BILATERAL ANTERIOR TIBIAL ARTERY PROXIMAL OCCLUSIONS WITH DISTAL RE

  Patient problems: Bruise/Contusion; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23301106 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED A PERICARDIAL EFFUSION, LEADING TO CANCELLATION OF THE PROCEDURE. DURING A PULMONARY VEIN ISOLATION CRYOABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, A POLAR SHEATH WAS SELECTED FOR USE. WHILE GAINING ACCESS AND CONSCIOUS SEDATION (LOCAL ANESTHESIA), THE PATIENT'S BLOOD PRESSURE DROPPED, WITH A SYSTOLIC READING OF 80MMHG. THE PROCEDURE WAS CONTINUED. UPON THE INTRODUCTION OF ICE INTO THE HEART, THE PHYSICIAN PERFORMED A BASELINE ASSESSMENT OF THE PERICARDIUM AND NOTED NO EFFUSIONS AT BASELINE. A CORONARY SINUS CATHETER AS WELL AS THIS POLARX WERE INTRODUCED. AN ELECTROPHYSIOLOGY STUDY WAS PERFORMED PRIOR TO TRANSEPTAL AND WAS NON RESULTANT. TRANSEPTAL WAS COMPLETED UNDER INTRACARDIAC ECHO WITH NRG NEEDLE AND NON-BOSTON SCIENTIFIC SHEATH. THE PHYSICIAN SUCCESSFULLY CROSSED, AND HEPARIN WAS ADMINISTERED. THE LEFT SUPERIOR PULMONARY VEIN WAS WIRED, AND THE SHEATH WAS EXCHANGED FOR THE POLAR SHEATH. WHEN INTRODUCING THE POLAR SHEATH, PRESSURE WAS NEEDED, AND IT DID 'JUMP' WHEN CROSSING THE FOSSA OVALIS. THE POLARXFIT BALLOON WAS PREPPED AND INSERTED INTO THE LEFT ATRIUM. DURING MANIPULATION OF THE POLAR MAP THE PATI

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20843107 ↗
• DeathOct 2, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN ATRIAL FIBRILLATION, A CRBS POLARSHEATH WAS SELECTED FOR USE, HOWEVER AFTER THE SHEATH WAS INSERTED AND THE DILATOR WAS REMOVED, WHEN TRYING TO ASPIRATE THE SHEATH, AIR WAS SEEN. IT IS UNKNOWN IF THE STOPCOCK WAS AT THE CORRECT ORIENTATION AT THE TIME OF ASPIRATION, BUT THERE WAS NO FLUID IN THE SIDE PORT EITHER. THE PHYSICIAN HAD TROUBLE WITH TRANSSEPTAL. THEREFORE, IT WAS DECIDED TO REPLACE THE DEVICE AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN, IT WAS DISCARDED AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17853433 ↗