ECHELON ENDOPATH GST45BRecalls & reported problems

Summary

The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 10705036014881), received between Apr 4, 2018 and Sep 21, 2026 — classified as 5 deaths, 33 injuries, 217 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (75 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 255 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Failure to Form Staple

  It was reported that during an unknown procedure, it was observed that some staples were malformed with irregular shape after firing. 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 50839638 ↗
• MalfunctionSep 17, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808614 ↗
• MalfunctionAug 31, 2026Failure to Fire

  It was reported that during an Unknown procedure the GST reload couldn't fire properly.Was surgery delayed due to the reported event? Unknown,Was procedure successfully completed? Unknown,Were fragments generated? Unknown,If yes, were they removed easily without additional intervention? Unknown,Patient Status/ Outcome / consequences: No,Patient Consequence Description/Was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? No incidence of infection or inflammation,Was other medical intervention (e.g. X-rays, additional procedures, prescriptions, OTC, revision) required: Unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50526539 ↗
• MalfunctionAug 31, 2026Failure to Form Staple

  It was reported that during an Unknown surgery, after fired, noted the staples malformed. Changed the another device to complete surgery. There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525487 ↗
• MalfunctionAug 21, 2026Failure to Fire

  Initial 45 stapler used did not fully fire during the procedure. Stapler was removed and surgeon reviewed the stapler to find if error occurred with usage. A second stapler was opened and loaded with a new blue load; however it also failed to fire completely. A third stapler was then opened with a different lot number thinking it was a batch of staplers malfunctioning. The third stapler was then tried with a white staple load and fired completely. All three staplers and blue loads were wasted on patients chart. Blue Loads: GST45B LOT:816D72 EXP:10-31-28, LOT:931C65 EXP:07-31-27.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50378914 ↗
• MalfunctionAug 10, 2026Failure to Fire

  It was reported that during a Laparoscopic Lobectomy, it was observed that the device would not fire. Two devices had the same issue. Changed to a new one to complete the procedure. There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195289 ↗
• MalfunctionAug 10, 2026Failure to Fire

  It was reported that during a Laparoscopic Lobectomy, it was observed that the device would not fire. Two devices had the same issue. Changed to a new one to complete the procedure. There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195285 ↗
• MalfunctionJul 27, 2026Ejection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024713 ↗
• MalfunctionJul 27, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019161 ↗
• MalfunctionJun 25, 2026Material Integrity Problem

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS DAMAGED AND PARTIALLY BROKEN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622210 ↗
• MalfunctionJun 25, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON REQUESTED TO USE ECHELON 3000 WITH A GST45B BLUE RELOAD AND WHILE THE TECH WAS LOADING THE RELOAD INTO THE STAPLER CARTRIDGE DECK THE PLASTIC ON THE RIGHT SIDE CRACKED OFF. THE RELOAD WAS DISCARDED AND ANOTHER RELOAD WAS INSERTED. NO DELAY OR PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622112 ↗
• MalfunctionJun 25, 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 25621438 ↗
• MalfunctionJun 24, 2026Ejection Problem; Separation Problem

  IT WAS REPORTED THAT DURING A VATS PROCEDURE, THE NURSE TRIED RELOADING THE PSEE45A WITH A GST45B, BUT COULD NOT INSERT AND SNAP PROPERLY TO THE CARTRIDGE JAW. AFTER INSPECTION, THEY FOUND THE METAL AT THE PROXIMAL PART OF THE GST45B WAS BENT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25609309 ↗
• MalfunctionJun 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 25445853 ↗
• 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 25429065 ↗
• 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 25429063 ↗
• 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 25428823 ↗
• 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 25428821 ↗
• 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 25428770 ↗
• MalfunctionJun 2, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY. AFTER FIRED, NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES 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 25364048 ↗
• MalfunctionMay 28, 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 25321477 ↗
• MalfunctionMay 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE DOCTOR INSERTED THE STAPLER AND ATTEMPTED TO FIRE IT FAILED TO STAPLE THE TISSUE. THE STAPLER WAS REMOVED, AND A NEW CARTRIDGE WAS REQUESTED. ANOTHER CARTRIDGE WAS OPENED, INCLUDING ONE FROM THE SAME LOT AS THE PREVIOUS ONE, AND AFTER POSITIONING THE STAPLER, FIRING AND STAPLING WERE PERFORMED SUCCESSFULLY. WAS THERE ANY DAMAGE OR LOSS REPORTED BY THE PATIENT OR USER? NO. WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230285 ↗
• MalfunctionMay 18, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE FAILED TO COMPLETE FIRING CYCLE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202903 ↗
• MalfunctionMay 11, 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 25140305 ↗
• MalfunctionMay 7, 2026Material Integrity Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED GASTRECTOMY, THE CARTRIDGE WAS ATTACHED TO THE DEVICE, IT DID NOT FIT PROPERLY, AND THE PROXIMAL END APPEARED SLIGHTLY LIFTED. THE DEVICE WAS NOT USED FOR THE PATIENT. THE CARTRIDGE COLOR WAS BLUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115701 ↗