ECHELON FLEX PSEE45ARecalls & reported problems
Ethicon Endo-Surgery, LLC · The ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneouslycut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX 45 Powered Plusinstruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freelyin both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operativesite.The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements fordisposing of the battery pack. Refer to the Battery Pack Disposal section.The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple legpoints during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used or improperly installed reloadfrom being refired or an instrument from being fired without a reload. · Class 2
Quick summary
This Ethicon ECHELON FLEX endoscopic stapler is a surgical instrument that cuts and staples tissue during surgery. Many reports describe the stapler failing to fire, being difficult to open or close, or jamming, and some describe staples not forming properly. The FDA database lists 1,255 reports, with 113 injuries and 5 deaths, and reports fell in the last 12 months, to 102 from 198. 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
- 1,258
- Deaths reported
- 5
- Injuries reported
- 114
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,258 adverse event reports that list this exact device (DI 10705036015352), received between Dec 28, 2017 and Sep 30, 2026 — classified as 5 deaths, 114 injuries, 1,139 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (437 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 Fire437
- Difficult to Open or Close434
- Failure to Form Staple183
- Mechanical Jam156
- Activation Failure106
- Adverse Event Without Identified Device or Use Problem63
- Activation Problem32
- No Apparent Adverse Event32
Patient problems
- No Clinical Signs, Symptoms or Conditions922
- No Consequences Or Impact To Patient209
- Hemorrhage/Blood Loss/Bleeding57
- No Code Available43
- Blood Loss28
- Failure to Anastomose22
- Insufficient Information12
- Pain9
Recent adverse event reports
The 25 most recent of 1,258 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult to Open or Close; No Apparent Adverse Event; Activation Failure; Activation Problem
It was reported that during a Liver Transplant procedure, the device was fired and subsequently jammed in the closed position, preventing the jaws from being opened. There was no patient consequence nor surgical delay reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 50947554 ↗MalfunctionSep 28, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919025 ↗MalfunctionSep 25, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899461 ↗MalfunctionSep 24, 2026Difficult to Open or Close
It was reported that, prior to a Liver Transplant procedure, the device was fired and subsequently jammed in the closed position, preventing the jaws from being opened. There was no patient consequence nor surgical delay reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884714 ↗MalfunctionSep 21, 2026Mechanical Problem; Failure to Fire; Difficult to Open or Close
It was reported that during a Laparoscopic Appendectomy the stapler was fired and it only fired about 1/4th of the way down. The surgeon attempted to use the emergency release but it initially did not work. The surgeon then attempted it again after a moment and it did finally release. The team had to pull another stapler that fired perfectly. No harm came to the patient and they were able to remain laparoscopic. Another psee45a stapler and reload were pulled to finish case with no issues. The device was returning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840397 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50829248 ↗MalfunctionAug 31, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50526491 ↗MalfunctionAug 26, 2026Failure to Fire; Difficult to Open or Close; Mechanical Jam; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459368 ↗MalfunctionAug 25, 2026Failure to Fire
It was reported that during an unspecified surgical procedure, it was observed that the device would not fire. Changed to a new one to complete the procedure. There was no patient consequence nor surgical delay reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50432540 ↗MalfunctionAug 25, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50431322 ↗MalfunctionAug 24, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410045 ↗InjuryAug 20, 2026Failure to Fire; Difficult to Open or Close
Patient problems: Insufficient Information
MAUDE report 50351211 ↗MalfunctionAug 19, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50323832 ↗MalfunctionAug 14, 2026Insufficient Device Problem Information
It was reported that during an unknown procedure, it was observed that the device did not respond after firing. A new PSEE45A was subsequently used, and the procedure was completed successfully. There was no adverse patient consequence nor surgical delay reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253022 ↗MalfunctionAug 4, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129789 ↗MalfunctionAug 3, 2026Positioning Failure; Failure to Cut; Difficult to Open or Close; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114918 ↗MalfunctionJul 27, 2026Failure to Fire; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046128 ↗MalfunctionJul 27, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50029512 ↗MalfunctionJul 1, 2026Failure to Cut
IT WAS REPORTED THAT DURING A GASTROPLASTY PROCEDURE, WHEN ACTIVATING THE ECHELON FLEX PLUS REF PSEE45A LAPAROSCOPIC LINEAR STAPLER, THE SAME STAPLED, BUT DID NOT CUT THROUGH THE TISSUE SEPARATION. THE RELOAD WAS CHANGED TWICE TO MAKE SURE THAT IT WOULD NOT BE A DEFECT IN THE RELOAD BUT IT WAS NECESSARY TO OPEN ANOTHER STAPLER. WAS THERE ANY REPORTED PATIENT OR USER HARM? UNKNOWN WAS THERE A SIGNIFICANT DELAY? UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25677566 ↗MalfunctionJun 24, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE MANUAL OVERRIDE PANEL ON THE MAIN BODY WAS DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25611373 ↗MalfunctionJun 24, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25611042 ↗MalfunctionJun 17, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE FAILED TO DEPLOY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538084 ↗MalfunctionJun 17, 2026Difficult to Open or Close; Mechanical Jam; Activation Failure
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE KNIFE MOVED TO THE DISTAL END BUT DID NOT RETURN KNIFE AUTOMATICALLY. KNIFE REVERSE BUTTON DID NOT WORK. USED MANUAL OVERRIDE LEVER TO RETURN KNIFE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537413 ↗MalfunctionJun 17, 2026Difficult to Open or Close
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT AFTER THEY INSTALLED THE RELOAD AND CLOSED THE JAW, THEY COULD NOT OPEN THE JAW ANYMORE. ANOTHER DEVICE WAS USED 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 25537228 ↗MalfunctionJun 9, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25448503 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.