ECHELON ENDOPATH GST45WRecalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 10705036014928), received between Jan 31, 2018 and Sep 28, 2026 — classified as 1 death, 39 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (53 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Dec 11, 2023Open, Classified

   There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.

   Z-0834-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916695 ↗
• MalfunctionSep 20, 2026Device Markings/Labelling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834833 ↗
• MalfunctionSep 20, 2026Device Markings/Labelling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834832 ↗
• MalfunctionAug 24, 2026Failure to Fire

  It was reported that during an unspecified surgical procedure, it was observed that the device could not be fired properly. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409146 ↗
• MalfunctionJul 27, 2026Failure to Form Staple; No Apparent Adverse Event

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50011982 ↗
• MalfunctionJul 13, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LUNG RESECTION, IT WAS OBSERVED THAT A FEW STAPLES WERE FORMED WITH IRREGULAR SHAPES AFTER FIRING; AND ANASTOMOTIC SITE WAS OOZING. SUTURE WAS USED TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25798166 ↗
• MalfunctionJun 15, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LUNG RESECTION PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. THEY USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25510948 ↗
• InjuryJun 8, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS THE DOCTOR SAID EVERYTHING WENT WELL AT FIRST GLANCE, WHEN HE IS GOING TO PERFORM THE POSTOPERATIVE CONTROL THE SAME DAY IN THE AFTERNOON HE NOTICES THE PATIENT WITH HER HEMODYNAMIC PARAMETERS ALTERED, THEY PERFORM AN ENDOSCOPY TO CHECK IF THERE IS ANY PROBLEM WITH THE SURGERY AND HE REALIZES THAT CLOSE TO THE STAPLE LINE OF THE GASTRIC POUCH AND THE GASTROJEJUNAL ANASTOMOSIS THAT HE PERFORMS MANUALLY, THE PATIENT HAS BRUISES AND CLOTS. WAS THERE ANY HARM TO THE REPORTED PATIENT OR USER? YES. DID THE PATIENT/USER REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE EVENT? YES. DESCRIPTION: THE PATIENT HAD TO UNDERGO SURGERY AGAIN, SINCE IN THE POSTOPERATIVE PERIOD THE DOCTOR PERFORMED AN ENDOSCOPY AND SHOWED THAT THE PATIENT HAD BRUISES AND CLOTS IN THE GASTROJEJUNAL ANASTOMOSIS, SO IT WAS DECIDED TO OPERATE ON HER AGAIN. DID THE PATIENT/USER REQUIRE PROLONGED HOSPITALIZATION AS A RESULT OF THE EVENT? UNKNOWN. WHAT IS THE PATIENT/USER STATUS AFTER THE EVENT? NOW IT'S OKAY. WAS THERE A SIGNIFICANT DELAY?

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

  MAUDE report 25428825 ↗
• InjuryJun 8, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS THE DOCTOR SAID EVERYTHING WENT WELL AT FIRST GLANCE, WHEN HE IS GOING TO PERFORM THE POSTOPERATIVE CONTROL THE SAME DAY IN THE AFTERNOON HE NOTICES THE PATIENT WITH HER HEMODYNAMIC PARAMETERS ALTERED, THEY PERFORM AN ENDOSCOPY TO CHECK IF THERE IS ANY PROBLEM WITH THE SURGERY AND HE REALIZES THAT CLOSE TO THE STAPLE LINE OF THE GASTRIC POUCH AND THE GASTROJEJUNAL ANASTOMOSIS THAT HE PERFORMS MANUALLY, THE PATIENT HAS BRUISES AND CLOTS. WAS THERE ANY HARM TO THE REPORTED PATIENT OR USER? YES DID THE PATIENT/USER REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE EVENT? YES. DESCRIPTION: THE PATIENT HAD TO UNDERGO SURGERY AGAIN, SINCE IN THE POSTOPERATIVE PERIOD THE DOCTOR PERFORMED AN ENDOSCOPY AND SHOWED THAT THE PATIENT HAD BRUISES AND CLOTS IN THE GASTROJEJUNAL ANASTOMOSIS, SO IT WAS DECIDED TO OPERATE ON HER AGAIN. DID THE PATIENT/USER REQUIRE PROLONGED HOSPITALIZATION AS A RESULT OF THE EVENT? UNKNOWN WHAT IS THE PATIENT/USER STATUS AFTER THE EVENT? NOW IT'S OKAY. WAS THERE A SIGNIFICANT DELAY?

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

  MAUDE report 25428824 ↗
• MalfunctionJun 2, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE PACKAGING OF THE DEVICE WAS DAMAGED. CHANGED TO ANOTHER TWO TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364857 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336738 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333147 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25332235 ↗
• MalfunctionApr 21, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945001 ↗
• MalfunctionApr 9, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT SOME STAPLES WERE MALFORMED WITH IRREGULAR SHAPE (WITH STRAIGHT LEG) AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE PROCEDURE AND USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835401 ↗
• MalfunctionFeb 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ALLEGEDLY DEFECTIVE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366570 ↗
• MalfunctionFeb 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ALLEGEDLY DEFECTIVE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298468 ↗
• MalfunctionFeb 6, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283074 ↗
• MalfunctionFeb 6, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282708 ↗
• MalfunctionJan 16, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PULMONARY SEGMENTECTOMY, WHEN THE CIRCULATING NURSE OPENED THE CARTRIDGE PACKAGE AND GAVE IT TO THE SCRUB NURSE, THE CARTRIDGE PAN WAS BROKEN. THE SALES REP ATTENDED THE OPERATION AND DETERMINED THAT THERE WAS NO NEGLIGENCE ON THE PART OF THE NURSE AND THAT THE PROBLEM WAS DUE TO A PRODUCT ASSEMBLY FAILURE. AS IT HAD NOT YET BEEN USED, THERE WAS NO IMPACT ON THE PATIENT. THE CARTRIDGE COLOR WAS WHITE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100016 ↗
• MalfunctionJan 7, 2026Separation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN LAPAROSCOPIC UROLOGICAL PROCEDURE, THE CARTRIDGE WAS USED AT THE 1ST FIRING, AND THE CARTRIDGE WOULD NOT FIT PROPERLY WHEN TRYING TO LOAD THE 2ND FIRING. AFTER TRYING SEVERAL TIMES AND STILL NOT BEING ABLE TO LOAD, IT WAS FOUND THAT THE CARTRIDGE PAN (WHICH HAD ALREADY BEEN SENT AS A DEFECT) WAS STILL LEFT TO THE MAIN BODY WHEN CHECKED THE MAIN BODY. THE PART REMAINING IN THE MAIN BODY WAS REMOVED WITH FORCEPS AND LOADED. THE DOCTOR WANTED TO KNOW WHY THIS WAS POSSIBLE. THE CARTRIDGE COLOR WAS WHITE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990041 ↗
• MalfunctionJan 6, 2026Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE GST45W RELOAD COULD NOT MATCH WITH THE GST GUN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975681 ↗
• MalfunctionDec 2, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A GASTROPLASTY PROCEDURE, DURING THE OPENING OF THE KIT, A PACKAGE WAS IDENTIFIED CONTAINING ONE LOOSE STAPLE INSIDE THE SEAL, COMPROMISING THE USE OF THE PACKAGE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693471 ↗
• MalfunctionNov 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED BY THE KEY ACCOUNT MANAGER THAT THE CLINIC RECEIVED BATCHES OF PRODUCTS (SPECIFIED IN THE CONTRACT AS ETHICON PRODUCTS) THAT WERE NOT SHIPPED TO OUR WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657203 ↗
• MalfunctionNov 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ALLEGEDLY DEFECTIVE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524445 ↗