ENGAGE™ C408509Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734053037), received between Jul 9, 2018 and Jun 10, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

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.

• InjuryJun 10, 2025Material Separation; Material Separation

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH SEPARATED INTO TWO PIECES. ONE HALF OF THE SHEATH WAS ABLE TO BE REMOVED FROM THE PATIENT, BUT THE OTHER HALF OF THE SHEATH REQUIRED A SNARE FOR REMOVAL. IMAGING WAS USED TO ACCOUNT FOR ALL PIECES. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22179130 ↗
• MalfunctionNov 26, 2024Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  DURING A REDO TYPICAL FLUTTER PROCEDURE, THE ADVISOR HD GRID BECAME ENTANGLED IN THE PATIENT ANATOMY REQUIRING SURGICAL REMOVAL OF THE DEVICE. AFTER POSITIONING THE CORONARY SINUS CATHETER, THE ADVISOR HD GRID CATHETER WAS PLACED INSIDE THE PATIENT AND MAPPING BEGAN IN THE RIGHT ATRIUM. THE CATHETER WAS DIFFICULT TO MANEUVER, BECAME STUCK, AND ATTEMPTS TO REMOVE THE CATHETER FROM THE ENGAGE INTRODUCER WERE UNSUCCESSFUL. IT WAS THEN ATTEMPTED TO REMOVE BOTH THE CATHETER AND INTRODUCER TOGETHER, HOWEVER ONLY THE INTRODUCER CAME OUT. DAMAGE WAS THEN NOTED ON THE INTRODUCER. ANOTHER INTRODUCER WAS USED, AND THE CATHETER WAS CUT IN HALF IN AN ATTEMPT TO REMOVE IT, HOWEVER IT WAS UNSUCCESSFUL. A VASCULAR SURGEON WAS THEN CALLED IN AND REMOVED THE INTRODUCER THAT WAS USED FOR THE CORONARY SINUS CATHETER AND THE NEW INTRODUCER THAT WAS USED TO TRY TO GET THE CATHETER OUT. THIS ALLOWED THE CATHETER TO BE REMOVED. UPON REMOVAL, A RED STRUCTURE ALLEGED TO BE A CLOT, OR A SMALL PART OF THE VEIN COULD BE SEEN. THE PROCEDURE WAS THEN STOPPED WITH NO FURTHER COMPLICATIONS. PER THE ADVISOR HD GRID CATHETER INSTRUCTIONS FOR USE, AN 8.5F MINIMUM INTRODUCER SHOULD BE USED. THE ENGAGE INTRODUCER USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787140 ↗
• MalfunctionJul 9, 2018Fracture; Difficult to Remove

  WHILE OBTAINING ACCESS FOR AN ABLATION, A VENOUS SHEATH WAS ATTEMPTED TO BE FLUSHED BY PHYSICIAN AND PHYSICIAN WAS UNABLE TO DO SO. IT WAS THEN DETERMINED THAT THE SHEATH WAS FRACTURED AND APPROXIMATELY 5 CM OF THE 11 CM SHEATH WAS LEFT IN THE PATIENT. MULTIPLE PHYSICIANS WERE CALLED TO ASSIST WITH REMOVAL INCLUDING VASCULAR SURGERY. AFTER CUTDOWN, THE FRACTURED SHEATH WAS REMOVED. THE PATIENT REMAINED STABLE, BUT THE EPS STUDY AND SVT ABLATION WERE ABORTED. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY WITH NO REPORTED COMPLICATIONS POST OP. AWAITING RESPONSE FROM MANUFACTURER, THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7669394 ↗