AcQGuide 900002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857042007012), received between Feb 3, 2021 and Mar 15, 2021 — 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.

• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HISTORY: A MALE PATIENT (AGE (B)(6); WEIGHT (B)(6) LBS) WAS TREATED ON (B)(6) 2021. THE PATIENT WAS BEING TREATED FOR ATRIAL FIBRILLATION. DESCRIPTION OF THE EVENT: IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE EP LAB FOR A DE NOVO PAROXYSMAL ATRIAL FIBRILLATION ABLATION. THE PATIENT WAS IN NORMAL SINUS RHYTHM WITH FREQUENT PREMATURE ATRIAL CONTRACTIONS (PAC). THE PHYSICIAN PLACED THE ABBOTT¿ ENSITE PRECISION¿ CARDIAC MAPPING SYSTEM (ESI) AND THE ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ (HD GRID) INTO THE LEFT ATRIUM (LA) TO DO A CONTACT MAP, MEASURE VOLTAGE, AND DO A LOCAL ACTIVATION TIME (LAT) MAP TO CONFIRM PAC WAS LEFT SIDED. AFTER THIS, A PULMONARY VEIN ISOLATION (PVI) WAS DONE USING ESI AND CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ (TACTICATH¿). A STANDARD WIDE ANTRAL CIRCUMFERENTIAL ABLATION (WACA) APPROACH WAS USED. AFTER PVI WAS FINISHED, THE AGILIS NXT STEERABLE INTRODUCER SHEATH WAS EXCHANGED FOR THE ACQGUIDE® MAX STEERABLE SHEATH (ACQGUIDE MAX). THE ACQMAP® 3D IMAGING AND MAPPING CATHETER (ACQMAP CATHETER) WAS THEN PLACED INTO THE LA VIA ACQGUIDE MAX. AN ULTRASOUND ANATOMY WAS CREATED AND EDITED, THEN A SINGLE POSITION RECORDING WAS MADE W

  Patient problems: Pericardial Effusion

  MAUDE report 11490158 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HISTORY: A FEMALE PATIENT ((B)(6) WAS TREATED ON (B)(6) 2019. THE PATIENT'S HISTORY INCLUDED A PREVIOUS ABLATION IN 2013 TO TREAT THE PATIENT'S ATRIAL FIBRILLATION (AF). THE PATIENT WAS CARDIOVERTED IN (B)(6) 2018. DESCRIPTION OF THE EVENT: ON (B)(6) 2019, A SERIOUS ADVERSE EVENT (AE) WAS REPORTED DURING THE ACUTUS CLINICAL STUDY (RECOVER AF). IT WAS REPORTED THAT POST PROCEDURE THE PATIENT DEVELOPED HYPOTENSION AND A DROP IN BLOOD PRESSURE. A CT SCAN SHOWED A SMALL ARTERIOVENOUS FISTULA IN THE GROIN. THERE WAS NO EVIDENCE OF RETROPERITONEAL BLEEDING. THE DROP IN BLOOD PRESSURE WAS VIEWED TO BE EXTERNAL BLEEDING FROM A SHEATH REMOVAL RATHER THAN INTERNALLY. THE PATIENT WAS DIAGNOSED WITH A VENOUS ACCESS SITE COMPLICATION (AV FISTULA) THAT LED TO ANEMIA AND REQUIRED A BLOOD TRANSFUSION. TWO UNITS WERE ANTICIPATED BUT FOLLOWING THE FIRST INFUSION, THE PATIENT WAS SUSPECTED OF HAVING A TRANSFUSION REACTION (PYREXIA). THE SECOND UNIT WAS NOT ADMINISTERED. IT WAS REPORTED THAT THE AE WAS "DEFINITELY" RELATED TO PROCEDURE. THE REPORT SHOWED THERE WAS NO POSSIBLE OR PROBABLE RELATIONSHIP TO ACUTUS MEDICAL (ACM) DEVICES. FOLLOWING A SITE MONITORING VISIT, AN UPDATE WAS MADE TO THE

  Patient problems: Fistula

  MAUDE report 11273458 ↗