EEA TRIEEAXL21MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521593084), received between Jan 8, 2025 and Feb 12, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. 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.

• MalfunctionFeb 12, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, THE CIRCULAR STAPLER WAS USED AND THE WHITE ANVIL TIP FELL OFF OF THE ANVIL AND WOULD NOT STAY ON AFTER PLACEMENT INTO THE PATIENT. THE SECOND ANVIL TIP IN THE PACKAGE WAS ALSO ATTEMPTED BUT SIMILARLY FELL OFF AND WOULD NOT STAY ON. AS A RESULT, THE PROCEDURE WAS EXTENDED BY 15-20 MINUTES AND REQUIRED THE USE OF AN ORVIL WITH CIRCULAR STAPLER TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323899 ↗
• MalfunctionJan 9, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROUX-EN-Y GASTRIC BYPASS (RYGB), IT WAS VERY DIFFICULT TO REMOVE THE STAPLER FROM THE ANASTOMOSIS. THE SURGEON NEEDED TO USE GRASPERS AND AN ASSISTANT TO HELP HOLD THE TISSUE FORWARD, AS WELL AS PULL AND WIGGLE IT OUT, SO THAT THE USER COULD REMOVE THE DEVICE, WHICH WAS PUTTING A LOT OF STRESS ON THE ANASTOMOSIS. A POSITIVE AIR LEAK TEST WAS NOTED. TO RESOLVE THE ISSUE, SUTURING WAS DONE TO THE PATIENT WHICH CAUSES AN EXTRA 5-10 MINUTE SURGICAL TIME.

  Patient problems: Failure to Anastomose

  MAUDE report 21114474 ↗
• MalfunctionJan 8, 2025Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS INVOLVING THE EEA STAPLER, AFTER FIRING THE STAPLER THE DEVICE WAS DIFFICULT TO REMOVE FROM THE CAVITY AND THE STAPLE LINE WAS FOUND TO BE INCOMPLETE WITH A HOLE PRESENT. AS A RESOLUTION, SUTURING WAS PERFORMED AS A REPLACEMENT FOR THE STAPLE LINE. THE SURGICAL TIME WAS EXTENDED BY 10-15 MINUTES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 21103924 ↗