CONTOURRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 871
- Deaths reported
- 2
- Injuries reported
- 120
- Recalls
- 0
We found 4 models of CONTOUR by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 871 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2017 and Jun 25, 2026 — classified as 2 deaths, 120 injuries, 749 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (281 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CONTOUR problems
Device problems
- Failure to Form Staple281
- Failure to Fire253
- Difficult to Open or Close103
- Material Integrity Problem65
- Failure to Cut48
- Adverse Event Without Identified Device or Use Problem39
- Insufficient Device Problem Information38
- Break28
Patient problems
- No Clinical Signs, Symptoms or Conditions385
- No Consequences Or Impact To Patient378
- No Code Available50
- Failure to Anastomose38
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
- Insufficient Information15
- Unspecified Tissue Injury12
- Hemorrhage/Blood Loss/Bleeding5
CONTOUR models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONTOUR CS40GSTAPLE, IMPLANTABLE1 death682 reports
- CONTOUR CS40BSTAPLE, IMPLANTABLE1 death108 reports
- CONTOUR CR40GSTAPLE, IMPLANTABLE76 reports
- CONTOUR CR40BSTAPLE, IMPLANTABLE5 reports
Recent CONTOUR adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionApr 16, 2026Failure to Fire; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER JAMMED WHEN THE SURGEON TRIED TO FIRE IT. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897358 ↗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 ↗InjuryFeb 9, 2026Failure to Fire; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE UNK OPERATION, A SITUATION OCCURRED THAT IS DIFFICULT TO EXPLAIN: AFTER TRANSECTION OF THE RECTUM BELOW THE STAPLE LINE, THE RECTUM WAS OPEN. (NORMALLY, THE CONTOUR STAPLER PLACES STAGGERED STAPLE ROWS ON BOTH SIDES OF THE BOWEL AND DIVIDES IT BETWEEN THE STAPLE LINES. TECHNICALLY, IT SHOULD NOT BE POSSIBLE FOR THE REMAINING RECTUM TO BE OPEN.) THE UNEXPECTED SITUATION RESULTED IN THE INABILITY TO CREATE A NEW ANASTOMOSIS BETWEEN THE COLON AND THE RECTUM. CONSEQUENTLY, THE PATIENT MUST LIVE PERMANENTLY WITH A STOMA.
Patient problems: Pneumothorax
MAUDE report 24292744 ↗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 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 ↗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 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 ↗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 ↗
Other Ethicon Endo-Surgery, LLC products
- Harmonic ACE9 models · 12,862 reports
- ECHELON FLEX7 models · 9,393 reports · 1 recall
- Harmonic13 models · 8,752 reports · 2 recalls
- ECHELON ENDOPATH31 models · 6,543 reports · 2 recalls
- LIGACLIP26 models · 3,254 reports
- ENDOPATH37 models · 2,785 reports
- ECHELON CIRCULAR4 models · 2,532 reports
- ECHELON Flex ENDOPATH7 models · 2,334 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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