AcQGuide MAX 900200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850027837017), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON INSERTING THE ACQGUIDE MAX SHEATH TO REPLACE THE BAYLIS SHEATH THAT WAS INSIDE THE PATIENT AND HAD BEEN USED TO ACHIEVE TRANSSEPTAL ACCESS, THE PATIENT DEVELOPED ST ELEVATION ON THE SURFACE EKG AND HYPOTENSION WITH A SYSTOLIC BLOOD PRESSURE LEVEL OF APPROXIMATELY 50. A VIZIGO SHEATH WAS ALSO INSIDE THE PATIENT AT THE TIME OF THE EVENT, AND ABLATION ON THE RIGHT ATRIUM HAD ALREADY BEEN PERFORMED PRIOR TO THE REPORTED EVENT USING A BIOSENSE WEBSTER SMARTTOUCH ABLATION CATHETER. THE PATIENT WAS IN ATRIAL FIBRILLATION AND ENERGY SHOCK CARDIOVERSION WAS DELIVERED TO INDUCE SINUS RHYTHM AND STABILIZE THE LOW BLOOD PRESSURE. THE HYPOTENSION AND ST ELEVATION SUBSIDED AFTER APPROXIMATELY 3 MINUTES FOLLOWING CARDIOVERSION DELIVERY, AND THE PROCEDURE RESUMED WITHOUT FURTHER ISSUES. THERE WERE NO PATIENT COMPLICATIONS OR ABNORMAL CLINICAL SYMPTOMS REPORTED POST PROCEDURE. THE PHYSICIAN SUGGESTED THAT THE EPISODE MAY HAVE BEEN RELATED TO AIR ENTERING THE PATIENT DURING SHEATH INSERTION, AND NOTED THAT THE SHEATH HAD BEEN PROPERLY FLUSHED PRIOR TO THE PROCEDURE. AIR EMBOLISM IS A LABELED POTENTIAL ADVERSE EFFECT ASSOCIATED WITH THE USE OF THE DEVICE. USER GUIDANCE HAS B

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 16584365 ↗