EEA TRIEEAXL25XTORVILRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521827660), received between Jan 22, 2026 and Sep 29, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that four days postoperatively, an atypical anastomotic leak occurred. No intraoperative issues were reported; the tissue donuts were reported as fine, with no abnormal tissue or tension observed. Additional surgery was performed.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 50937283 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose

  MAUDE report 50935454 ↗
• MalfunctionJan 22, 2026Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN IVOR LEWIS ESOPHAGECTOMY, THE SUTURE WAS DIFFICULT TO REMOVE FROM THE ORVIL (ORAL ANVIL) PRIOR TO FIRING. EXCESSIVE FORCE WAS REQUIRED TO ATTEMPT REMOVAL, AND THE SUTURE WOULD NOT MOVE DESPITE MULTIPLE ATTEMPTS, INCLUDING MOVING THE ANVIL SIDE TO SIDE, IN AND OUT, AND TWISTING. THE SURGEON DECIDED TO FIRE THE STAPLER WITH THE SUTURE POTENTIALLY IN THE STAPLE LINE. AFTER FIRING, THE SUTURE REMAINED ON THE ANVIL. UPON REMOVAL OF THE STAPLER, SUTURE PIECES WERE RETRIEVED FROM THE CHEST CAVITY, WITH A TOTAL OF THREE PIECES IDENTIFIED: THE SUTURE REEL AND TWO ADDITIONAL PIECES. THE PROCEDURE WAS EXTENDED BY 15 MINUTES DUE TO THESE ISSUES. THE PATIENT WAS ALIVE WITH NO INJURY, AND WAS REPORTEDLY RECOVERING AS EXPECTED ON POSTOPERATIVE DAY TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152272 ↗