N/A CDH29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1,617 adverse event reports that list this exact device (DI 10705036003465), received between Nov 27, 2017 and Sep 25, 2026 — classified as 17 deaths, 414 injuries, 1,186 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (613 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 1,617 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported via Journal Article: This complaint is from a literature source. The following literature cite has been reviewed:Tulina I, Tsugulya PB, Kim V, He M, Balaban V, Tsarkov P. Short- and Long-term Outcomes of 3-Row Vs 2-Row Circular Staplers for Low Colorectal Anastomosis After Total Mesorectal Excision: A Single-Center, Randomized, Single-Blind, Phase III Trial (THREESTAPLER Study). Dis Colon Rectum. 2026 Oct 1;69(10):2500-2510. doi: 10.1097/DCR.0000000000004381. Epub 2026 Aug 10. PMID: 42572962; PMCID: PMC13585166.This study compared the efficacy of 3-row versus 2-row circular staplers in reducing anastomotic leakage rates. A total of 154 patients underwent low anterior resection with total mesorectal excision and were randomly assigned into 2 groups in a 1:1 ratio. The end-to-end colorectal anastomosis was performed using either a manual 2-row circular stapler (Ethicon CDH29A, 29¿mm) or a manual 3-row circular stapler (Mirus MCS-29R3, 29¿mm).Reported complications:2-row circular stapler (Ethicon CDH29A, 29¿mm)n=12 anastomotic leakageTreatment: not reported.n=2 anastomotic strictureTreatment: not reported.In conclusion, the 3-row stapler was noninferior to the 2-row st

  Patient problems: Failure to Anastomose; Obstruction/Occlusion

  MAUDE report 50896692 ↗
• MalfunctionSep 21, 2026Failure to Fire

  It was reported that during and Unknown procedure, 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 50839346 ↗
• MalfunctionAug 31, 2026Failure to Form Staple

  It was reported that during an Unknown surgery, after fired, noted some staples malformed with irregular shape. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525077 ↗
• MalfunctionAug 31, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521262 ↗
• MalfunctionAug 26, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453845 ↗
• MalfunctionAug 26, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that during an Unknown procedure the staples came out of the clamp before use, requiring a change of clamp.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453712 ↗
• MalfunctionAug 17, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278248 ↗
• MalfunctionAug 13, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235957 ↗
• MalfunctionAug 10, 2026Device Misassembled During Manufacturing /Shipping

  It was reported that during an Unknown surgery, open the packing and noted that some staples fell off. 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 50193953 ↗
• MalfunctionAug 10, 2026Device Misassembled During Manufacturing /Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193505 ↗
• MalfunctionAug 3, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50121755 ↗
• MalfunctionJul 7, 2026Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN PREPARING TO USE THE INSTRUMENTS, IT WAS FOUND THAT THE SHIITAKE MUSHROOM TIP AND THE PUNCTURE END DID NOT FIT PROPERLY, CAUSING THE DOCTOR TO BE UNEASY AND REPLACED THE INSTRUMENTS. HAVE THERE BEEN REPORTS OF INJURIES FROM PATIENTS OR USERS? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735900 ↗
• MalfunctionJun 18, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE 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 25553316 ↗
• MalfunctionJun 16, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE PROCTRECTOMY 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 25523423 ↗
• MalfunctionJun 16, 2026Failure to Cut

  IT WAS REPORTED THAT DURING THE PROCTRECTOMY SURGERY, AFTER FIRED, NOTED THAT THE TISSUE WAS NOT CUT . THEN CHANGED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523333 ↗
• MalfunctionJun 16, 2026Failure to Cut

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THERE WAS NO TISSUE TRANSECTION. THE ANVIL REMAINED STUCK, EVEN AFTER OPENING THE STAPLER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523298 ↗
• MalfunctionJun 15, 2026Failure to Fire; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE UNK SURGERY, THE NAILS ARE EXPOSED OUTSIDE THE WAREHOUSE AND COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511577 ↗
• MalfunctionJun 15, 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 25510506 ↗
• MalfunctionJun 10, 2026Failure to Cut

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THAT THE TISSUE WAS NOT CUT, THEN CHANGED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460472 ↗
• MalfunctionJun 8, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, COULD NOT DRAW BACK SAFETY TRIGGER. COULD NOT DRAW BACK THE SAFETY TRIGGER DURING THE SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436924 ↗
• MalfunctionMay 27, 2026Ejection Problem

  IT WAS REPORTED THAT DURING THE UNK SURGERY, OPEN THE PACKING AND NOTED ANVIL CANNOT BE ATTACHED. 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 25302014 ↗
• MalfunctionMay 27, 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 25301794 ↗
• MalfunctionMay 26, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED AND OOZING OCCURRED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. 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 25284376 ↗
• MalfunctionMay 26, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, 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 25281088 ↗
• MalfunctionMay 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE PROCTECTOMY PROCEDURE, 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 25264740 ↗

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-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-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-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-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-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-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-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-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-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-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-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.