Titan SGS Standard Gastric Stapler SGS23RbRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00851677007133), received between May 5, 2023 and Sep 16, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "AFTER THE DISSECTED STOMACH WAS REMOVED, IT WAS INFLATED AND A LEAK ALONG THE STAPLE LINE WAS NOTICED. ONLY THE EXTRACTED PORTION OF THE STOMACH HAD THIS ISSUE. IT OCCURRED ROUGHLY AT THE 50% MARK OF THE STAPLER". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23062255 ↗
• MalfunctionSep 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "AFTER THE DISSECTED STOMACH WAS REMOVED, IT WAS INFLATED AND A LEAK ALONG THE STAPLE LINE WAS NOTICED. ONLY THE EXTRACTED PORTION OF THE STOMACH HAD THIS ISSUE. IT OCCURRED ROUGHLY AT THE 50% MARK OF THE STAPLER". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23057680 ↗
• InjuryAug 7, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "PATIENT HAD A SIGNIFICANT HEMOGLOBIN LOSS (6 POINTS OVERALL) BUT IS STABLE RIGHT NOW. WE DIDN'T WITNESS ANY EVIDENT PRODUCT MALFUNCTION OR MISUSE DURING THE TRIAL".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22738775 ↗
• InjuryJul 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT "SUFFERED SIGNIFICANT BLEEDING FROM THE SUTURE LINE" AND "WENT INTO HEMORRHAGIC SHOCK DURING THE NIGHT, FORCING THE SURGEONS TO PERFORM AN EMERGENCY PROCEDURE TO PUT A STOP TO THE BLEEDING. WE DIDN'T WITNESS ANY EVIDENT PRODUCT MALFUNCTION OR MISUSE DURING THE TRIAL".

  Patient problems: Exsanguination

  MAUDE report 22648104 ↗
• MalfunctionJul 17, 2025Failure to Fire; Failure to Fire

  IT IS REPORTED AS "TITIAN SGS STAPLER WOULD NOT GO INTO FIRING MODE. AFTER TIME OUT WAS ACKNOWLEDGED AND GREEN BUTTON WAS PUSHED AGAIN IT WOULD GO INTO TIME OUT MODE AGAIN. WE HAD TO OPEN THE STAPLER TO REMOVE THE STOMACH. HOWEVER, AFTER THE STOMACH WAS REMOVED THE DEVICE WOULD NOT CLOSE. AMANUAL BAILOUT CLOSE WAS PERFORMED TO GET THE JAWS TO CLOSE FOR REMOVAL OF THE STAPLER.NO PATIENT INJURY OR CONSEQUENCE REPORTED. CURRENT CONDITION OF THE PATIENT REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534968 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED A LEAK ON (B)(6) 2023 FOLLOWING A SLEEVE GASTRECTOMY PROCEDURE COMPLETED ON (B)(6) 2023, WHICH HAD USED A TITAN SGS23RB STAPLER. A SMALL DEFECT WAS OBSERVED MORE POSTERIOR OF THE FUNDUS. IT WAS REPORTED THAT IT LOOKED LIKE THE FUNDUS WAS POSSIBLY FOLDED. RE-OPERATION/SURGICAL INTERVENTION WAS REQUIRED TO RESOLVE THE LEAK. THE PATIENT WAS RELEASED AFTER RE-OPERATION/SURGICAL INTERVENTION. STANDARD BARIATRICS WAS INFORMED OF THE LEAK ON (B)(6) 2023.

  Patient problems: Failure to Anastomose

  MAUDE report 16882147 ↗