ECHELON CIRCULAR CDH29PRecalls & reported problems
Ethicon Endo-Surgery, LLC · ECHELON CIRCULAR Powered Stapler · Class 2
Quick summary
This Ethicon Echelon Circular is a powered surgical stapler. Its 1,563 reports describe many cases of the stapler failing to fire, and others describe staples not forming, parts not ejecting or packaging problems. The reports mention 6 deaths and 559 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
- 1,571
- Deaths reported
- 6
- Injuries reported
- 558
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,571 adverse event reports that list this exact device (DI 10705036015383), received between Apr 17, 2019 and Sep 29, 2026 — classified as 6 deaths, 558 injuries, 1,007 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (626 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 Fire626
- Adverse Event Without Identified Device or Use Problem444
- Ejection Problem283
- Failure to Form Staple166
- No Apparent Adverse Event67
- Failure to Cut59
- Patient Device Interaction Problem54
- Failure to Eject38
Patient problems
- No Clinical Signs, Symptoms or Conditions909
- Failure to Anastomose431
- No Consequences Or Impact To Patient97
- No Code Available88
- Hemorrhage/Blood Loss/Bleeding73
- Insufficient Information55
- Unspecified Tissue Injury53
- Fever36
Recent adverse event reports
The 25 most recent of 1,571 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935416 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935352 ↗MalfunctionSep 25, 2026Failure to Fire
It was reported that during an Unknown surgery, could not fire. Changed another four to use , still 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 50896434 ↗MalfunctionSep 25, 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 50896271 ↗MalfunctionSep 25, 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 50896209 ↗MalfunctionSep 25, 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 50896177 ↗MalfunctionSep 25, 2026Failure to Cut; Insufficient Device Problem Information
It was reported that during an unknown surgery, during the firing of the circular manual stapler, the plastic washer was not heard to break, which created confusion in the operating room and that the treating physician at the time was not sure if a correct staple formation and cut was achieved. The doctor wants to know why the plastic washer did not sound. He also comments that the cut line was not formed correctly. Was there any harm to the reported patient or user? No.Was there a significant delay? Yes.How long was it delayed (minutes)? 15 minutes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896096 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that, during an unknown surgery, although some bleeding occurred, the doctor has determined it is not caused by the device. The patient is under observation. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50872051 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that, during a rectal operation, although bleeding occurred, it is not caused by the device. The patient is under observation. There were no adverse consequences to the patient. No further information is available.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50872029 ↗MalfunctionSep 23, 2026Failure to Fire
It was reported that during an Unknown procedure the device was opened to sterile field, inserted by surgeon to rectum for use and an attempt was made to fire stapler while inserted in patient. The stapler did not fire as expected, however green check mark on device was shown indicating stapler was fired although it was not. a new stapler needed to be opened to complete this portion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867390 ↗MalfunctionSep 22, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858798 ↗MalfunctionSep 22, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858632 ↗MalfunctionSep 22, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857214 ↗MalfunctionSep 22, 2026Failure to Form Staple; Appropriate Device Problem Term/Code Not Available
It was reported that during an Unknown procedure the CDH29P was used in surgery and opened and used as per ODP. Upon firing and checking anastomosis with scope - discovered that there is a visible misfired staple and some bleeding along staple line.Was there any reported patient or user harm? No Was there a significant delay? No
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50852887 ↗MalfunctionSep 17, 2026Self-Activation or Keying
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806129 ↗MalfunctionSep 17, 2026Failure to Fire
It was reported that during an Unknown procedure, It does not fire after installing the battery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805930 ↗MalfunctionSep 17, 2026Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available
It was reported that during an ileostomy reversal procedure, the device battery was properly installed. When the surgeon removed the anvil, staple legs were observed protruding from the side of the device. The surgeon then attempted to close the device in order to remove the anvil however, the device would not fully close and was considered unsafe for use. No patient consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802254 ↗MalfunctionSep 14, 2026Ejection Problem
It was reported that during an Anastomosis that the CDH29P was used and the device¿s trocar continued to retract as the surgeon tried to open to connect it to the anvil. No delay or patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754513 ↗MalfunctionSep 14, 2026Device Remains Activated
It was reported that during an Unknown procedure the Circular stapler did not stop cutting after firing. The surgeon had to remove the battery in order for it to stop.Was there any reported patient or user harm? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752313 ↗MalfunctionSep 10, 2026Ejection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714079 ↗MalfunctionSep 10, 2026Failure to Fire
It was reported that during an Unknown procedure, the device did not fire. No additional information was provided. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713691 ↗InjurySep 2, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50572057 ↗InjurySep 2, 2026Patient Device Interaction Problem
Patient problems: Insufficient Information
MAUDE report 50571813 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Failure to Anastomose; Unspecified Tissue Injury
MAUDE report 50571442 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Failure to Anastomose; Unspecified Tissue Injury
MAUDE report 50571400 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.