CONTOUR CS40GRecalls & reported problems

Summary

The FDA's MAUDE database contains 682 adverse event reports that list this exact device (DI 10705036012405), received between Nov 29, 2017 and Jun 25, 2026 — classified as 1 death, 99 injuries, 582 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (225 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 25 most recent of 682 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE CONTOUR STAPLER ¿MISFIRED¿. SURGEON HAD TO OPEN ANOTHER STAPLER TO COMPLETE THE SURGERY. THE PROCEDURE WAS DELAYED BY 25 MINUTES AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25625850 ↗
• MalfunctionMay 25, 2026Unintended Ejection

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, RELOAD CARTRIDGE DISLODGED WHILE REMOVING SAFETY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270290 ↗
• MalfunctionMay 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CONTOUR GUN DID NOT DEPLOY THE PINS UPON FIRING DURING THE PROCEDURE. HENCE A NEW CONTOUR GUN WAS OPENED AND USED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264520 ↗
• MalfunctionJan 16, 2026Unintended Ejection

  IT WAS REPORTED THAT DURING THE UNK SURGERY, THE HEAD WAS UNSTABLE DURING USED AND FALLS OFF WHEN FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099109 ↗
• MalfunctionJan 13, 2026Material Integrity Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, COULD NOT PROPERLY FIRE AS CARTRIDGE ANVIL BROKE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058985 ↗
• MalfunctionJan 13, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN ANTERIOR RESECTION PROCEDURE, WHEN ATTEMPTING TO STAPLE ON TISSUE, THE CS40G STAPLER WAS UNABLE TO FIRE AND STAPLE ON THE TISSUE. THIS STAPLER WAS THEN ISOLATED AND A NEW CS40G WAS OPENED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058951 ↗
• MalfunctionJan 12, 2026Unintended Ejection

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE THE NURSE ADVISED THE DEVICE WOULD NOT HOLD THE CARTRIDGE. NO OTHER DETAILS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038712 ↗
• MalfunctionDec 9, 2025Unintended Ejection; Failure to Fire; Unintended Ejection; Failure to Fire

  IT WAS REPORTED THAT DURING A OPEN ANTERIOR RESECTION, THE CONTOUR (CS40G) HAVE BEEN USED BUT THE RELOAD POPPED OUT DURING FIRING AND CAUSE INCOMPLETE STAPLE LINE. SURGEON USED MANUAL SUTURING TO COMPLETE AFTER THAT. THERE WAS NO REPORTED IMPACT TO PATIENT BUT TAKE EXTRA 2 HOUR TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759142 ↗
• MalfunctionDec 9, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE TYVEK PACKAGING RIPPED WHEN THE STAPLER WAS OPENED AND THE DEVICE COULD NOT BE USED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759125 ↗
• MalfunctionNov 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLES THAT DO NOT PENETRATE THE WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511274 ↗
• MalfunctionNov 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLES THAT DO NOT PENETRATE THE WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511259 ↗
• MalfunctionAug 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A BOWEL RESECTION WHEN THE NURSE REMOVED THE SAFETY LOCK TO RELEASE AND DROP THE LOAD, BOTH, THE LOAD AND STRUCTURE HOLDING IT WENT DOWN AS WELL - THE MATERIAL PARTS AND THE PLASTIC ON TOP. EVERYTHING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22871474 ↗
• MalfunctionAug 21, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LAP NEPHRECTOMY SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED AND OOZING OCCURRED. SUTURE WAS USED TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

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

  MAUDE report 22865606 ↗
• InjuryJul 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AND ANTERIOR RESECTION SURGERY OF THE RECTUM, DURING THE PACKAGING PHASE OF COLORECTAL ANASTOMOSIS DURING THE INSERTION OF THE CIRCULAR STAPLER, THE SUTURE OF THE RECTAL STUMP PERFORMED WITH A CONTOUR STAPLER, GREEN CHARGE FORMED AT FIRST CORRECTLY, PRESENTED DEHISCENCE WITH COMPLETE OPENING OF THE RECTAL STUMP SUTURE RHYME. THE SURGERY WAS DELAYED. THE SURGEON WAS NO LONGER ABLE TO PERFORM ANASTOMOSIS AND THE PATIENT WAS GIVEN A STOMA; THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Failure to Anastomose

  MAUDE report 22511788 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION SURGERY OF THE RECTUM, DURING THE PACKAGING PHASE OF COLORECTAL ANASTOMOSIS DURING THE INSERTION OF THE CIRCULAR STAPLER, THE SUTURE OF THE RECTAL STUMP PERFORMED WITH A CONTOUR STAPLER, GREEN CHARGE FORMED AT FIRST CORRECTLY, PRESENTED DEHISCENCE WITH COMPLETE OPENING OF THE RECTAL STUMP SUTURE RHYME. THE SURGEON WAS NO LONGER ABLE TO PERFORM ANASTOMOSIS AND THE PATIENT WAS GIVEN A STOMA. THERE WAS A SURGICAL DELAY. THE TIME IS UNK.

  Patient problems: Failure to Anastomose

  MAUDE report 22296520 ↗
• MalfunctionJun 11, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE. AFTER FIRED, NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING. TO STOP OOZING WITH COMPRESSION HEMOSTASIS. 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 22183522 ↗
• MalfunctionMay 8, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCTECTOMY 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 21984844 ↗
• MalfunctionMay 1, 2025Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN SURGEON TRIED TO USE IT, SOME OF STAPLER LEGS PROJECTED FROM CARTRIDGE DECK. THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941549 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO AN ANTERIOR RESECTION THE PATIENT RETURNED TO THEATRE WITHIN THE SAME WEEK AND UNDERWENT A LAPAROTOMY. FOLLOWING THE PROCEDURE, THE PATIENT HAD TO RETURN TO THEATRE DUE TO PERI SPLENIC INFECTED HEMATOMA.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 21722099 ↗
• MalfunctionMar 7, 2025

  ECHELON CURVED CUTTER STAPLER WOULD NOT WORK - "NOT FIRING." A NEW ECHELON STAPLER WAS BROUGHT INTO THE ROOM, AND THE NEXT ONE WOULD NOT WORK EITHER. DR SWITCHED TO THE TA 90 STAPLER. NO INJURY TO PATIENT. THE DEFECTIVE STAPLERS WILL BE RETURNED TO THE MANUFACTURER FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546641 ↗
• MalfunctionFeb 24, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND AFTER FIRING THE CONTOUR STAPLER, SURGEON SAID THAT THERE WAS STILL AN OPEN LUMEN AFTER FIRING. WHEN THE SPECIMEN WAS INSPECTED, STAPLES HAD DEPLOYED IN A LINEAR FORMATION. THE SURGEON THEN PACKED THE RECTUM, AS HE HAD DECIDED TO DO AN AP RESECTION BEFORE FIRING THE STAPLER. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446131 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA CLINICAL TRIAL PATIENT (B)(4) EXPERIENCE, ANEMIA, PELVIC ABSCESS. RELATIONSHIP TO STUDY DEVICE: POSSIBLY RELATED.

  Patient problems: Abscess; Anemia

  MAUDE report 21403068 ↗
• MalfunctionFeb 10, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE IS NOT WORKING THE SURGERY WAS DELAYED 10 MINUTES. CHANGED THE STAPLER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344334 ↗
• MalfunctionFeb 3, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE WIRE OF THE DEVICE DOESN'T WORK, SO THEY COULDN'T FIRE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292440 ↗
• MalfunctionJan 28, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE SURGERY. AFTER FIRED, NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING. TO STOP OOZING WITH COMPRESSION HEMOSTASIS. 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 21251152 ↗