EEA TRIEEAXL31XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521593152), received between Jul 20, 2022 and Sep 15, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K172361, K192330, K221005); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that during a procedure, after firing, the anvil detached and was stuck in the colon. The anvil could be tilted after firing. To resolve the issue, a rigid scope was inserted to retrieve and remove the anvil from the colon.

  Patient problems: Insufficient Information

  MAUDE report 50766529 ↗
• MalfunctionJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN AN OPEN HARTMAN¿S REVERSAL, AFTER FIRING TO CREATE AN END-TO-END ANASTOMOSIS, THE STAPLE LINE HAD A LEAK. A LEAK TEST WAS PERFORMED AND RESULTED POSITIVE. SUTURING WAS DONE AS A STAPLE LINE REPLACEMENT. THE PROCEDURE WAS EXTENDED FOR ABOUT ONE HOUR TO OVERSEW THE DAMAGED TISSUE AND CREATE A TEMPORARY ILEOSTOMY.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 21230359 ↗
• MalfunctionJul 2, 2024Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE LINE WAS INCOMPLETE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES. ANOTHER CIRCULAR STAPLER WAS USED TO COMPLETE THE CASE.

  Patient problems: Failure to Anastomose; Tissue Breakdown; Unspecified Tissue Injury

  MAUDE report 19660959 ↗
• MalfunctionMar 11, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SIGMOIDECTOMY, WHEN THE CLAMP WAS REMOVED AFTER STAPLING, THE ANVIL BECAME DISCONNECTED FROM THE CLAMP AND CLUNG TO THE INTESTINAL LUMEN; IT GOT STUCK IN THE RECTUM. THERE WAS A SMALL HEMATOMA ON THE COLORECTAL ANASTOMOSIS. THE ANVIL WAS REMOVED BY USING THE SURGEON'S FINGERS.

  Patient problems: Hematoma

  MAUDE report 18882696 ↗
• MalfunctionFeb 16, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC LAPAROSCOPIC PROCEDURE, RESECTION OF SIGMOID COLON, ONLY ONE DONUT WAS FOUND ON THE ANVIL. THE DOCTOR DID A LEAK TEST, AND EVERYTHING WAS FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18725747 ↗
• MalfunctionJun 20, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, AFTER FIRING THE STAPLER, IT WAS FOUND THAT THERE WAS A HOLE IN THE BOWEL AS THE STAPLE LINE IS INCOMPLETE. THE SURGICAL TIME WAS EXTENDED BY 30-45 MINUTES THE DEFECT IN THE BOWEL WAS REPAIRED VIA SUTURING.

  Patient problems: Failure to Anastomose

  MAUDE report 17164935 ↗
• InjuryJul 20, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN LOW ANTERIOR RESECTION PROCEDURE, WHILE THE DOCTOR WAS WORKING WITHIN THE DISTAL COLON, THE DEVICE WAS PARTIALLY FIRED, THE STAPLE LINE WAS INCOMPLETE, AND THE STAPLE WAS POORLY FORMED. THE DOCTOR SAID THERE WAS A HOLE IN THE ANASTOMOSIS. THE RESOLVE THE INCOMPLETE STAPLE LINE, THE SURGEON OVER SEWED IT. TO PREVENT THE ANASTOMOSES FOR A LEAK, THE SURGEON HAD TO HAND SEW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15066024 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172361, K192330, K221005. One submission often covers many models, so check the product and lot details in each record.

• Z-0070-2019 · Aug 17, 2018 · Terminated
  EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a