N/A CDH33ARecalls & reported problems

Summary

The FDA's MAUDE database contains 275 adverse event reports that list this exact device (DI 10705036003472), received between Dec 4, 2017 and May 29, 2026 — classified as 5 deaths, 76 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (84 reports).

13 other recalls cover devices cleared under the same FDA submission (K983536); they may or may not involve this specific model.

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 275 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Ejection Problem

  IT WAS REPORTED THAT BEFORE THE UNK SURGERY, AFTER FIRED AND NOTED ANVIL CANNOT RETURN TO ITS ORIGINAL POSITION. 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 25334787 ↗
• MalfunctionMay 26, 2026Ejection Problem

  IT WAS REPORTED THAT DURING THE UNK SURGERY, THE ANVIL COULD NOT BE PULLED OUT. 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 25284662 ↗
• MalfunctionFeb 20, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK 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 24405787 ↗
• MalfunctionJan 5, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK SURGERY, COULD NOT FIRE. 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 23955983 ↗
• MalfunctionDec 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED TO A 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 23771754 ↗
• MalfunctionOct 17, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, COULD NOT FIRE. 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 23322371 ↗
• MalfunctionAug 19, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, COULD NOT FIRE. 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 22839610 ↗
• MalfunctionAug 14, 2025Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION THE CIRCULAR STAPLER DIDN'T FIRE AND CREATE ANASTOMOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806658 ↗
• MalfunctionAug 4, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AFTER THE SURGEON OPENED THE PACKAGING OF THE CIRCULAR STAPLER, HE INFORMED THAT IT WAS NOT APPROACHING BETWEEN THE WARHEAD AND OTHER STAPLER STRUCTURE, HE FOUND THE SPACE SPORTY AND PREFERRED NOT TO USE IN THE PATIENT FOR FEAR OF SOME CLINICAL COMPLICATION, BEING NECESSARY TO OPEN ANOTHER STAPLER. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22703971 ↗
• MalfunctionJul 11, 2025Failure to Cut; Failure to Fire; No Apparent Adverse Event; Failure to Eject; Failure to Cut; Failure to Fire; No Apparent Adverse Event; Failure to Eject

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION THE CDH29B GOT STUCK AFTER FIRING AND HAS TO REDO THE ENTIRE ANASTOMOSIS. THE SURGERY WAS DELAYED 30 MINUTES.

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

  MAUDE report 22478428 ↗
• MalfunctionJun 24, 2025Failure to Fire; Ejection Problem; Failure to Fire; Ejection Problem

  IT WAS REPORTABLE THAT DURING AN UNKNOWN PROCEDURE THE STAPLER IS NOT COMPLETELY CLOSING THE OGIVE, NOT STAPLING THE FABRIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318524 ↗
• MalfunctionJun 23, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGICAL STAPLER DID NOT CLOSE THE ENTIRE WARHEAD. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306363 ↗
• MalfunctionJun 17, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ANVIL DID NOT REMOVE FROM THE TROCAR. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22234081 ↗
• DeathJun 11, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE AT THE TIME OF COLORECTAL ANASTOMOSIS WITH THE CIRCULAR STAPLER, THE EQUIPMENT FAILED, RESULTING IN APPROXIMATELY 50% OF OPEN INTESTINAL LIGHT. THIS FAILURE SERIOUSLY COMPROMISED PATIENT SAFETY AND PROCEDURE INTEGRITY. THE DIRECT CONSEQUENCES OF THIS FAILURE FOR THE PATIENT WERE: SIGNIFICANT INCREASE IN SURGICAL TIME; INCREASED CHANCE OF POSTOPERATIVE INFECTION; DECOMPENSATION OF PREEXISTING COMORBIDITIES; NEED FOR A NEW SURGICAL PROCEDURE FOR CORRECTION, WITH ALL RISKS ASSOCIATED WITH A REINTERVENTION. THE SURGERY WAS DELAYED. IT WAS NECESSARY TO PERFORM THE ANASTOMOSIS MANUALLY, AND AN ILEOSTOMY WAS REQUIRED.

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

  MAUDE report 22188465 ↗
• MalfunctionJun 11, 2025Insufficient Device Problem Information; Insufficient 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 22183054 ↗
• MalfunctionMay 27, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; Ejection Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLE GUN MISFIRED AND THE ANVIL OF THE DEVICE WAS STUCK IN THE PATIENT WITH TISSUE ATTACHED TO IT.

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

  MAUDE report 22087156 ↗
• MalfunctionMay 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE SURGERY, COULD NOT FIRE. 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 22087130 ↗
• MalfunctionMay 22, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAP COLON PROCEDURE WHILE USING THE CIRCULAR STAPLER, THE SURGEON NOTICED AFTER FIRING THAT THE STAPLE LINE WAS NOT PROPERLY FORMED, WITH SOME OF THE STAPLES VISIBLE ON THE LINE. IT WAS NECESSARY TO MAKE A REINFORCING SUTURE SINCE, AT SOME POINTS, THE MECHANICAL SUTURE WAS NOT WELL CLOSED. AN EXPERIENCED SURGEON IN THE USE OF THE MATERIAL REQUESTED THE OPENING OF A COMPLAINT FOR ANALYSIS. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT, 15 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069262 ↗
• MalfunctionMay 19, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A COLON RESECTION AS SOON AS THE STAPLER WAS REMOVED FROM ITS BOX, PROCEEDED TO UNPACK IT. WHEN HE TURNED THE ADJUSTMENT KNOB TO SEPARATE THE ANVIL STEM FROM THE PUNCH¿. IT DID NOT OPEN EASILY AS IT USUALLY DOES. THE DR. HAD TO APPLY A LOT OF FORCE AND FINALLY OPENED IT. IN ADDITION, WHEN HE TRIED TO TURN THE KNOB AGAIN, IT DID NOT OPEN OR CLOSE MANUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047360 ↗
• MalfunctionApr 23, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTRECTOMY 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 21890040 ↗
• MalfunctionApr 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION THE DEVICE MISFIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881634 ↗
• MalfunctionApr 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A COLON RESECTION SURGERY, COULD NOT FIRE. 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 21872288 ↗
• MalfunctionMar 6, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A COLECTOMY 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 21538147 ↗
• MalfunctionFeb 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, COULD NOT FIRE. 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 21404312 ↗
• MalfunctionJan 24, 2025

  THE ANVIL AND SPIKE PUSHED THROUGH THE PROXIMAL TRANSECTION SITE POSTERIOR TO THE STAPLE LINE. AFTER SEVERAL ATTEMPTS THE ANVIL SPIKE WOULD NOT DISENGAGE FROM THE ANVIL UTILIZING VARIOUS TECHNIQUES. A NEW STAPLER WAS OBTAINED AND PLACED. THE ANVIL PLACED WITHOUT THE SPIKE USING A PURSE STRING TO CLOSE AROUND THE ENTEROTOMY. THE ENDOSCOPIC ENDONASAL APPROACH (EEA) WAS PLACED VIA THE RECTUM AND THE DISTAL SPIKE DEPLOYED. THE TWO ENDS WERE CONNECTED, THE STAPLER CLOSED, AND THE STAPLER FIRED. INSPECTION OF THE ANASTOMOTIC DONUTS SHOWED AN INTACT DISTAL DONUT, BUT THE PROXIMAL DONUT WAS NOT INTACT. LEAK TEST WAS POSITIVE, AND THE DEFECT FOUND ANTERIORLY.

  Patient problems: Failure to Anastomose

  MAUDE report 21228908 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983536. One submission often covers many models, so check the product and lot details in each record.

• Z-1275-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1274-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1271-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1276-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1268-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1267-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1272-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1278-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1269-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1277-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1270-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1273-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-0672-2018 · Oct 23, 2017 · Terminated
  Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.