EEA TRIEEAXL25MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521593107), received between Oct 30, 2025 and Mar 16, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Failure to Align

  IT WAS REPORTED THAT PREOPERATIVELY, DURING SET-UP ISSUES AND PRIOR TO FIRING, THE ANVIL FLIPPED OR TILTED BEFORE ACTIVATION. THE DEVICE WAS REPLACED WITH A NEW PRODUCT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612253 ↗
• MalfunctionJan 29, 2026No Device Output; Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE, WHILE CREATING THE POUCH, THE WHITE TROCAR TIP WAS LOCKED INTO PLACE BUT FELL OUT AND WOULD NOT STAY IN OR LOCK IN PLACE WHEN TRYING TO REINSERT IT. THE AUDIBLE FEEDBACK WAS VERY FAINT UPON FIRING, AND TACTILE FEEDBACK WAS NOT NOTICEABLE UPON FIRING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214947 ↗
• InjuryJan 29, 2026Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A TOTAL GASTRECTOMY, DURING THE ANASTOMOSIS OF THE ESOPHAGEAL STUMP AND THE ELEVATED JEJUNUM, THE CIRCULAR STAPLER HANDLE AND THE ORAL ANVIL COULD NOT BE ATTACHED WHICH RESULTED IN THE ANASTOMOSIS BEING UNABLE TO BE PERFORMED. THE PROCEDURE WAS CHANGED FROM LAPAROSCOPY TO LAPAROTOMY AND THORACOTOMY. THE SURGICAL TIME WAS EXTENDED FOR THREE HOURS. IT WAS REPORTED THAT THE PATIENT HAD ACUTE ABDOMINAL PAIN POST-OPERATIVELY.

  Patient problems: Abdominal Pain; Failure to Anastomose; Laceration(s)

  MAUDE report 24209853 ↗
• MalfunctionJan 28, 2026Device Difficult to Setup or Prepare; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE ROUX EN Y, WHEN CREATING GASTRIC POUCH, THE WHITE TIP HAD FALLEN OUT OF ANVIL BEFORE BEING INSERTED, AND THE SURGEON COULD NOT GET IT TO STAY BACK IN THE ANVIL SO PROCEEDED WITHOUT USING THE WHITE ACCESSORY TIP. THEN, WHILE FIRING, AFTER THE SURGEON COMPLETED ALL THE CORRECT STEPS FOR FIRING, WHEN SQUEEZED THE HANDLE, THE USER DID NOT HEAR AN AUDIBLE CLICK NOR COULD REALLY FEEL ANYTHING, BUT THE HANDLE WAS COMPLETELY SQUEEZED. THERE WAS ALSO A TORN SPOT NEAR THE STAPLE LINE THAT THE SURGEON THEN STITCHED UP. TO RESOLVE THE ISSUE, ANOTHER CIRCULAR STAPLER WAS USED.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24205751 ↗
• MalfunctionJan 28, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE WHITE TIP JUST FALL OUT OF THE ANVIL PRIOR TO INSERTION, THE SURGEON TRIED TO PUT THE TIP BACK IN AND IT CONTINUED TO FALL OUT. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205722 ↗
• MalfunctionJan 19, 2026No Device Output; Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y FOR THE CREATION OF THE GASTRIC POUCH, THE WHITE ANVIL TIP FELL OUT AS SOON AS THE ANVIL WAS INSIDE THE PATIENT. THERE WAS NO AUDIBLE FEEDBACK AND NO TACTILE FEEDBACK DURING DEVICE FIRING. A THOROUGH INSPECTION OF THE STAPLE LINE WAS PERFORMED AND A LEAK TEST WAS CONDUCTED, WITH THE STAPLE LINE APPEARING FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111926 ↗
• MalfunctionOct 30, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY PROCEDURE, THE DISTAL (JEJUNAL) DOUGHNUT WAS MISSING AFTER FIRING THE CIRCULAR STAPLER, RESULTING IN AN INCOMPLETE DOUGHNUT. THE PROXIMAL DOUGHNUT WAS COMPLETE, AND THE ANASTOMOSIS APPEARED SATISFACTORY UPON VISUAL INSPECTION. BOTH GASTROSCOPY AND LEAK TESTS WERE PERFORMED AND YIELDED SUCCESSFUL RESULTS. SUTURING WAS DONE AS STAPLE LINE REINFORCEMENT TO ADDRESS THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23431021 ↗