CONTOUR CR40GRecalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10705036001430), received between May 18, 2018 and May 14, 2026 — classified as 7 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (38 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177618 ↗
• MalfunctionMar 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAR CASE AND DIDN'T GET STAPLED INSTEAD ALL STAPLES CAME OUT WITHOUT FORMING B SHAPE. ANOTHER RELOAD WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PROCEDURE WAS DELAYED BY 20 MINUTES. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524830 ↗
• MalfunctionFeb 10, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE STAPLE LINE IS NOT COMPLETE WHEN FIRING, IT WAS CUT & STAPLE ONLY HALF OF BOWEL STRUM. USE SUTURE TO SUTURING ANASTOMOSIS. THE SURGERY WAS DELAYED BY 10 MINUTES AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306198 ↗
• MalfunctionJan 15, 2026Failure to Cut

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE BLADE DOES NOT ADVANCE TO THE END. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085449 ↗
• MalfunctionDec 30, 2025Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CR40G MISFIRED DURING SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923046 ↗
• MalfunctionOct 15, 2025Unintended Ejection; Failure to Cut; Unintended Ejection; Failure to Cut

  IT WAS REPORTED THAT DURING A HARTMAN PROCEDURE, SURGEONS WERE PLACING THE DEVICE ON THE SIGMOID COLON AND COMPRESSED IT WELL. AFTER FIRING, THEY NOTICED THAT THE TISSUE WASN'T BEEN CUT BUT STAPLED. THE SURGEON HAD TO TRANSECT THE TISSUE WITH SCISSORS, AND RE-ENFORCED THE STAPLE LINE WITH SUTURE. SURGEON TOLD THAT THE TISSUE WASN'T TOO THICK AND COMPRESSIBLE. THERE WAS NO DIFFICULTY TO CLOSE THE HANDLE BUT HE NOTICED THE RELOAD WAS BIT LOOSE FROM THE DEVICE. THIS DEVICE IS RE-USED PIECE BUT WITH NEW RELOADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278036 ↗
• MalfunctionApr 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION A NEW CONTOUR GUN CS40G IS OPENED AND USED WELL IN RECTAL TRANSACTION IN SECOND FIRING DR. OPENED NEW RELOAD CR40G AND FIRED, HOWEVER, IN SECOND FIRING TRANSACTION HAPPENED BUT STAPLER PINS DID NOT GET DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873292 ↗
• MalfunctionFeb 6, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN ABDOMINOPERINEAL RESECTION THE STAPLE LINE WAS OPENED AFTER FIRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326604 ↗
• MalfunctionDec 12, 2024Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913596 ↗
• MalfunctionDec 10, 2024Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891955 ↗
• MalfunctionDec 4, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION THE CONTOUR IS ONLY SUTURED ON THE SPECIMEN SIDE BUT THE PATIENT SIDE IS NOT STAPLED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846530 ↗
• MalfunctionSep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BEFORE USING THE DEVICE, ALREADY FIRED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20150293 ↗
• MalfunctionAug 15, 2024Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, THE CR40G RELOAD DID NOT WORK PROPERLY. THERE WAS A 15 MINUTE DELAYED. USED ANOTHER CARTRIDGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996094 ↗
• MalfunctionAug 8, 2024Failure to Form Staple; Difficult to Open or Close; Insufficient Device Problem Information; Firing Problem; Failure to Form Staple; Difficult to Open or Close; Insufficient Device Problem Information; Firing Problem

  IT WAS REPORTED THAT DURING A LAR CASE USING CONTOUR GUN THEY OPENED A NEW GUN CS40G AND A NEW RELOAD CR40G. LOADED IT PROPERLY AS PER SOP. WHEN THEY TRIED FIRING IT WAS VERY HARD TO FIRE AND HAD AN DIFFICULT TIME CLOSING. ONCE FIRING AUDIBLE SOUND HEARD THE STAPLES ON THE LOWER JAW OF THE RELOAD MISFIRED AND DAMAGED THE TISSUE OF COLON. IT WAS A NIGHTMARE THAT NEW CR40G MISFIRED AND NO STAPLES WERE NOT FORMED DUE TO MISFIRE. THE DOCTOR HAD TO HAND SEW ANASTOMOSIS WHICH TOOK 2 HRS. THERE WAS A 2 HOUR DELAY IN SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. ANASTOMOSIS WAS DONE PROPERLY SO PATIENT DOING FINE.,

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 19942296 ↗
• MalfunctionJul 11, 2024Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CONTOUR RELOAD MISFIRED AND RECTAL STUMP OPENED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721298 ↗
• MalfunctionJun 27, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON WAS NOT ABLE TO FIRE RELOAD. THERE WAS NO SURGICAL DELAY. HE CHANGED THE INSTRUMENT AND FINISHED THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625718 ↗
• MalfunctionApr 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT FIRE WELL. NO OTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143384 ↗
• MalfunctionApr 2, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOAD MISFIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020495 ↗
• MalfunctionFeb 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE NURSE INSTALLED THE CARTRIDGE AND REMOVED THE SAFETY LOCK, BUT THE STAPLER WAS STICKING OUT OF THE GROOVE BY ABOUT 1MM. THE STAPLER WAS REMOVED, REPLACED WITH A NEW PRODUCT, AND SURGERY WAS PERFORMED. THE OPERATING ROOM NURSE SAID THAT UNLIKE BEFORE, OTHER CONTOUR CARTRIDGES FELT STIFF WHEN INSTALLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772906 ↗
• InjuryFeb 5, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAR THE CONTOUR WAS USED IN HIRSCHPRUNG DISEASED PATIENT AND THE DISTAL TRANSECTION WAS DONE USING THE CONTOUR AND WHILE CHECKING THE STAPLE LINE IT OPENED UP LEADING TO RE-ANASTAMOSIS OF THE PATIENT THE SURGERY WAS DELAYED 45 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Failure to Anastomose

  MAUDE report 18646193 ↗
• MalfunctionJan 30, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION THE SECOND FIRING OF THE LAR PROCEDURE, THE SECOND CARTRIDGE DIDN'T STAPLE IT ONLY CUT THE TISSUE. THE PROCEDURE WAS COMPLETED BY DOING HAND SEWN CLOSURE OF THE OPENED PART AND THEN THE END TO END ANASTOMOSIS WAS DONE USING A CIRCULAR STAPLER.THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609169 ↗
• MalfunctionDec 5, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE NURSE COULD NOT RELOAD THE CARTRIDGES. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18269859 ↗
• InjuryDec 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION THAT THE SURGEON USED A DEVICE TO ATTEMPT TO COMPLETE THE TRANSECTION FIRING DISTALLY AND THE STAPLER HAD AN ISSUE HOWEVER THE SURGEON WAS NOT SPECIFIC ON HIS DESCRIPTION OF WHAT HAPPENED. SURGEON ENDED UP HAND SUTURING THE ANASTOMOSIS AND GIVING THE PATIENT A TEMPORARY ILEOSTOMY. PATIENT SCHEDULED TO GO HOME 11/21/2023. A SECOND PROCEDURE WILL BE SCHEDULED AT SOME POINT TO REVERSE THE ILEOSTOMY.

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

  MAUDE report 18256795 ↗
• InjuryDec 4, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION THAT ON THE FIRST ATTEMPT TO FIRE THE DEVICE THE KNIFE CUT BUT NO STAPLES WERE DEPLOYED. SURGEON ENDED UP HAND SUTURING THE ANASTOMOSIS AND GIVING THE PATIENT A TEMPORARY ILEOSTOMY. PATIENT SCHEDULED TO GO HOME (B)(6) 2023. A SECOND PROCEDURE WILL BE SCHEDULED AT SOME POINT TO REVERSE THE ILEOSTOMY.

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

  MAUDE report 18256699 ↗
• MalfunctionNov 27, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLES DEPLOYED, BUT DID NOT CLOSE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211558 ↗