AcQCross Qx 900305Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850027837161), received between Apr 7, 2022 and Oct 13, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A CARDIAC TAMPONADE OCCURRED IN THE PATIENT'S LEFT ATRIUM WHILE UTILIZING THE ACQGUIDE MAX 2.0 SHEATH AND ACQCROSS MAX TRANSSEPTAL. THE TAMPONADE WAS SLOW LEAKING. REPORTEDLY, THE PHYSICIAN SUSPECTED THE CAUSE OF THE EVENT WAS THE .032 GUIDEWIRE. AN ACUTUS REPRESENTATIVE MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE HOWEVER FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

  Patient problems: Cardiac Tamponade

  MAUDE report 15595949 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A CARDIAC TAMPONADE OCCURRED IN THE PATIENT'S LEFT ATRIUM WHILE UTILIZING THE ACQGUIDE MAX 2.0 SHEATH AND ACQCROSS MAX TRANSSEPTAL. THE TAMPONADE WAS SLOW LEAKING. REPORTEDLY, THE PHYSICIAN SUSPECTED THE CAUSE OF THE EVENT WAS THE .032 GUIDEWIRE. AN ACUTUS REPRESENTATIVE MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE HOWEVER FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

  Patient problems: Cardiac Tamponade

  MAUDE report 15470556 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PHYSICIAN WAS PERFORMING DIRECT TRANSEPTAL PUNCTURE USING ACQGUIDE MAX 2.0 WITH ACQCROSS. FLUOROSCOPY LOOKED GOOD IN MULTIPLE VIEWS ONCE SYSTEM ENGAGED WITH FOSSA/SEPTUM. NEEDLE DEPLOYED, HOWEVER, PATIENT QUICKLY BECAME UNRESPONSIVE, RBBB ECG PATTERN AND BLOOD PRESSURE DROPPED SIGNIFICANTLY. CPR COMMENCED WHILE PHYSICIAN POSITIONED PERICARDIAL DRAIN UNDER ECHO. ONCE DRAIN IN SITU, PATIENT BECAME RESPONSIVE AGAIN AND BLOOD PRESSURE GRADUALLY IMPROVED. BLOOD CONTINUED TO BE DRAINED FROM PERICARDIUM FOR APPROX. 1 HOUR BEFORE BLEEDING HAD ALMOST STOPPED. PATIENT TRANSFERRED TO CCU FOR MONITORING AT LEAST OVERNIGHT. THE PATIENT WAS ABLE TO RETURN HOME 3 DAYS POST PROCEDURE. NO PRODUCT MALFUNCTION WAS REPORTED AS BEING RELATED TO THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 14088024 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT USING THE ACQGUIDE MAX (LN101953) AND ACQCROSS MAX (LN102010) TO GO TRANSEPTAL, THE DEVICE MOVED OFF THE SEPTUM AND PUNCTURED THE RIGHT ATRIAL WALL. SURGICAL REPAIR WAS COMPLETED ON THE PATIENT. THERE IS NO REPORT OR ALLEGATION OF AN ACUTUS PRODUCT MALFUNCTION.

  Patient problems: Cardiac Perforation

  MAUDE report 14048141 ↗