Echelon Endopath GST60TRecalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 10705036014720), received between Nov 29, 2017 and Sep 24, 2026 — classified as 2 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (46 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 25 most recent of 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 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 50883014 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THEY OBSERVED THREE SEQUENTIAL UNFORMED STAPLES AT THE FIRST FIRING USING ECHELON 3000 60MM AS THE STAPLE LEGS WERE STRAIGHT. UNFORMED STAPLES WERE FROM THE RIGHT SIDE OF CARTRIDGE - MIDWAY - OUTERMOST ROW. SILK SUTURES WERE USED TO OVERSEW AND SECURE THE AREA. TISSUE BEING STAPLED HAD CONSISTENT THICKNESS. SURGEON PRE-COMPRESSED BEFORE FIRING. ALL OTHER STAPLES APPEARED FULLY FORMED. THE STAPLER FIRED 10 MORE TIMES WITH 10 GST60T LOADS; ALL WITH FULLY FORMED STAPLES. HOWEVER, THEY WERE UNABLE TO IDENTIFY WHICH LOADS PRODUCED THE UNFORMED STAPLES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448057 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THEY OBSERVED THREE SEQUENTIAL UNFORMED STAPLES AT THE FIRST FIRING USING ECHELON 3000 60MM AS THE STAPLE LEGS WERE STRAIGHT. UNFORMED STAPLES WERE FROM THE RIGHT SIDE OF CARTRIDGE - MIDWAY - OUTERMOST ROW. SILK SUTURES WERE USED TO OVERSEW AND SECURE THE AREA. TISSUE BEING STAPLED HAD CONSISTENT THICKNESS. SURGEON PRE-COMPRESSED BEFORE FIRING. ALL OTHER STAPLES APPEARED FULLY FORMED. THE STAPLER FIRED 10 MORE TIMES WITH 10 GST60T LOADS; ALL WITH FULLY FORMED STAPLES. HOWEVER, THEY WERE UNABLE TO IDENTIFY WHICH LOADS PRODUCED THE UNFORMED STAPLES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448055 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THEY OBSERVED THREE SEQUENTIAL UNFORMED STAPLES AT THE FIRST FIRING USING ECHELON 3000 60MM AS THE STAPLE LEGS WERE STRAIGHT. UNFORMED STAPLES WERE FROM THE RIGHT SIDE OF CARTRIDGE - MIDWAY - OUTERMOST ROW. SILK SUTURES WERE USED TO OVERSEW AND SECURE THE AREA. TISSUE BEING STAPLED HAD CONSISTENT THICKNESS. SURGEON PRE-COMPRESSED BEFORE FIRING. ALL OTHER STAPLES APPEARED FULLY FORMED. THE STAPLER FIRED 10 MORE TIMES WITH 10 GST60T LOADS; ALL WITH FULLY FORMED STAPLES. HOWEVER, THEY WERE UNABLE TO IDENTIFY WHICH LOADS PRODUCED THE UNFORMED STAPLES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448054 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THEY OBSERVED THREE SEQUENTIAL UNFORMED STAPLES AT THE FIRST FIRING USING ECHELON 3000 60MM AS THE STAPLE LEGS WERE STRAIGHT. UNFORMED STAPLES WERE FROM THE RIGHT SIDE OF CARTRIDGE - MIDWAY - OUTERMOST ROW. SILK SUTURES WERE USED TO OVERSEW AND SECURE THE AREA. TISSUE BEING STAPLED HAD CONSISTENT THICKNESS. SURGEON PRE-COMPRESSED BEFORE FIRING. ALL OTHER STAPLES APPEARED FULLY FORMED. THE STAPLER FIRED 10 MORE TIMES WITH 10 GST60T LOADS; ALL WITH FULLY FORMED STAPLES. HOWEVER, THEY WERE UNABLE TO IDENTIFY WHICH LOADS PRODUCED THE UNFORMED STAPLES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448053 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THEY OBSERVED THREE SEQUENTIAL UNFORMED STAPLES AT THE FIRST FIRING USING ECHELON 3000 60MM AS THE STAPLE LEGS WERE STRAIGHT. UNFORMED STAPLES WERE FROM THE RIGHT SIDE OF CARTRIDGE - MIDWAY - OUTERMOST ROW. SILK SUTURES WERE USED TO OVERSEW AND SECURE THE AREA. TISSUE BEING STAPLED HAD CONSISTENT THICKNESS. SURGEON PRE-COMPRESSED BEFORE FIRING. ALL OTHER STAPLES APPEARED FULLY FORMED. THE STAPLER FIRED 10 MORE TIMES WITH 10 GST60T LOADS; ALL WITH FULLY FORMED STAPLES. HOWEVER, THEY WERE UNABLE TO IDENTIFY WHICH LOADS PRODUCED THE UNFORMED STAPLES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448051 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THEY OBSERVED THREE SEQUENTIAL UNFORMED STAPLES AT THE FIRST FIRING USING ECHELON 3000 60MM AS THE STAPLE LEGS WERE STRAIGHT. UNFORMED STAPLES WERE FROM THE RIGHT SIDE OF CARTRIDGE - MIDWAY - OUTERMOST ROW. SILK SUTURES WERE USED TO OVERSEW AND SECURE THE AREA. TISSUE BEING STAPLED HAD CONSISTENT THICKNESS. SURGEON PRE-COMPRESSED BEFORE FIRING. ALL OTHER STAPLES APPEARED FULLY FORMED. THE STAPLER FIRED 10 MORE TIMES WITH 10 GST60T LOADS; ALL WITH FULLY FORMED STAPLES. HOWEVER, THEY WERE UNABLE TO IDENTIFY WHICH LOADS PRODUCED THE UNFORMED STAPLES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448050 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THEY OBSERVED THREE SEQUENTIAL UNFORMED STAPLES AT THE FIRST FIRING USING ECHELON 3000 60MM AS THE STAPLE LEGS WERE STRAIGHT. UNFORMED STAPLES WERE FROM THE RIGHT SIDE OF CARTRIDGE - MIDWAY - OUTERMOST ROW. SILK SUTURES WERE USED TO OVERSEW AND SECURE THE AREA. TISSUE BEING STAPLED HAD CONSISTENT THICKNESS. SURGEON PRE-COMPRESSED BEFORE FIRING. ALL OTHER STAPLES APPEARED FULLY FORMED. THE STAPLER FIRED 10 MORE TIMES WITH 10 GST60T LOADS; ALL WITH FULLY FORMED STAPLES. HOWEVER, THEY WERE UNABLE TO IDENTIFY WHICH LOADS PRODUCED THE UNFORMED STAPLES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448047 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THEY OBSERVED THREE SEQUENTIAL UNFORMED STAPLES AT THE FIRST FIRING USING ECHELON 3000 60MM AS THE STAPLE LEGS WERE STRAIGHT. UNFORMED STAPLES WERE FROM THE RIGHT SIDE OF CARTRIDGE - MIDWAY - OUTERMOST ROW. SILK SUTURES WERE USED TO OVERSEW AND SECURE THE AREA. TISSUE BEING STAPLED HAD CONSISTENT THICKNESS. SURGEON PRE-COMPRESSED BEFORE FIRING. ALL OTHER STAPLES APPEARED FULLY FORMED. THE STAPLER FIRED 10 MORE TIMES WITH 10 GST60T LOADS; ALL WITH FULLY FORMED STAPLES. HOWEVER, THEY WERE UNABLE TO IDENTIFY WHICH LOADS PRODUCED THE UNFORMED STAPLES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448042 ↗
• MalfunctionMay 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THEY OBSERVED THREE SEQUENTIAL UNFORMED STAPLES AT THE FIRST FIRING USING ECHELON 3000 60MM AS THE STAPLE LEGS WERE STRAIGHT. UNFORMED STAPLES WERE FROM THE RIGHT SIDE OF CARTRIDGE - MIDWAY - OUTERMOST ROW. SILK SUTURES WERE USED TO OVERSEW AND SECURE THE AREA. TISSUE BEING STAPLED HAD CONSISTENT THICKNESS. SURGEON PRE-COMPRESSED BEFORE FIRING. ALL OTHER STAPLES APPEARED FULLY FORMED. THE STAPLER FIRED 10 MORE TIMES WITH 10 GST60T LOADS; ALL WITH FULLY FORMED STAPLES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322102 ↗
• MalfunctionMay 19, 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 25216829 ↗
• MalfunctionApr 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE 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 25031316 ↗
• MalfunctionApr 1, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE NOT FORMED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756888 ↗
• MalfunctionMar 26, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES MALFORMED AFTER FIRING. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. 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 24697351 ↗
• MalfunctionMar 26, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES MALFORMED AFTER FIRING. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. 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 24697343 ↗
• MalfunctionMar 24, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING AFTER FIRING. THEY USED COMPRESSION HEMOSTASIS TO STOP OOZING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

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

  MAUDE report 24676660 ↗
• MalfunctionMar 17, 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 24618016 ↗
• 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 24298472 ↗
• 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 24298290 ↗
• MalfunctionDec 23, 2025Difficult to Open or Close; Activation Failure; Difficult to Open or Close; Activation Failure

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE JAW ON THE DEVICE COULD NOT BE OPENED AFTER FIRING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881455 ↗
• MalfunctionDec 11, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT LOWER LOBECTOMY PROCEDURE, THE DEVICE WAS USED DURING A BRONCHIAL RESECTION AT THE 2ND FIRING, BUT ONE LEG OF THE STAPLE AT THE DISTAL SIDE DID NOT FORM AS INTENDED. THE LEG OF UNFORMED STAPLE WAS CUT WITH SCISSORS, AND ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THE CARTRIDGE COLOR WAS BLACK. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782334 ↗
• MalfunctionNov 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658135 ↗
• MalfunctionNov 26, 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 23657606 ↗
• MalfunctionNov 4, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466751 ↗
• MalfunctionNov 3, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. 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 23457217 ↗