ECHELON CIRCULAR CDH25PRecalls & reported problems
Ethicon Endo-Surgery, LLC · ECHELON CIRCULAR Powered Stapler · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Echelon Circular powered stapler is a surgical stapler. Its 644 reports mostly describe the stapler failing to fire during surgery, with some reports of staples not forming and parts not joining. The reports include 1 death and 126 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 653
- Deaths reported
- 1
- Injuries reported
- 126
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 653 adverse event reports that list this exact device (DI 10705036015376), received between Jul 26, 2019 and Sep 30, 2026 — classified as 1 death, 126 injuries, 526 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (351 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.
Reports received per month
Most reported problems
Device problems
- Failure to Fire351
- Adverse Event Without Identified Device or Use Problem107
- Ejection Problem94
- Failure to Form Staple87
- Failure to Cut33
- No Apparent Adverse Event21
- Failure to Eject18
- Patient Device Interaction Problem13
Patient problems
- No Clinical Signs, Symptoms or Conditions504
- Failure to Anastomose83
- No Consequences Or Impact To Patient27
- Hemorrhage/Blood Loss/Bleeding23
- Insufficient Information18
- Unspecified Tissue Injury15
- No Code Available13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
Recent adverse event reports
The 25 most recent of 653 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Form Staple; Appropriate Device Problem Term/Code Not Available
It was reported that during an Unknown surgery, after fired, noted some staples malformed with irregular shape. And then the staple line and cut line are both complete. noted oozing. Used suture 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 50945732 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935336 ↗MalfunctionSep 29, 2026Failure to Form Staple; Appropriate Device Problem Term/Code Not Available
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50932046 ↗MalfunctionSep 25, 2026Failure to Fire
It was reported that during an Unknown surgery, could not fire farther after fired a little. 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 50896670 ↗MalfunctionSep 25, 2026Failure to Fire
It was reported that during an Unknown surgery, could not fire farther after fired a little. 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 50896598 ↗MalfunctionSep 25, 2026Failure to Form Staple; Appropriate Device Problem Term/Code Not Available
It was reported that during an Unknown surgery, after fired, noted some staples malformed with irregular shape. And then the staple line and cut line are both complete. noted oozing. Used suture 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 50896165 ↗MalfunctionSep 22, 2026Failure 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 50858719 ↗MalfunctionSep 22, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858611 ↗MalfunctionSep 22, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857177 ↗MalfunctionSep 21, 2026Self-Activation or Keying
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844254 ↗MalfunctionSep 17, 2026Failure to Fire; No Apparent Adverse Event; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 50805536 ↗MalfunctionSep 16, 2026Self-Activation or Keying
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794422 ↗MalfunctionSep 15, 2026Self-Activation or Keying
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778040 ↗MalfunctionSep 14, 2026Failure to Fire
It was reported that, during an unknown surgery, the device could not be fired after connecting. Same anvil and another device were used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754542 ↗MalfunctionSep 1, 2026Failure to Form Staple; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541220 ↗MalfunctionAug 25, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50429407 ↗MalfunctionAug 14, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260426 ↗MalfunctionAug 13, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236615 ↗MalfunctionAug 12, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220475 ↗MalfunctionAug 11, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210401 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during a Sigmoid Resection procedure, the surgeon experienced an anastomotic leak where powered circular devices were utilized. One patient required a return to the operating room for a subsequent procedure. The patient experienced postoperative leak resulting in inflammation.
Patient problems: Failure to Anastomose; Inflammation
MAUDE report 50207892 ↗MalfunctionAug 10, 2026Delivered as Unsterile Product
It was reported that during an Unknown procedure the package was broken and was no longer sterile. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201073 ↗MalfunctionAug 10, 2026Failure to Fire; Noise, Audible
It was reported that during a Low Anterior Resection procedure, abnormal sound was detected and could not fire. Besides, cut washer was detached. 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 50197083 ↗MalfunctionJul 27, 2026Failure to Form Staple; Ejection Problem
It was reported that, during an unknown surgery, there have been report of difficulty in removing, and the staples that had unformed were found at the anvil. The customer inquired about whether that might be the cause. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038654 ↗MalfunctionJul 22, 2026Mechanical Jam; Ejection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25904727 ↗
Other Staple, implantable devices
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- Signia SIGPHANDLECovidien LP · STAPLE, IMPLANTABLE1 recall3 deaths5,356 reports
- ECHELON FLEX PSEE60AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- ENDOPATH ATS45Ethicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE2 deaths2,046 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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