ECHELON FLEX PVE35ARecalls & reported problems
Ethicon Endo-Surgery, LLC · Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, 35mm · Class 2
All models of ECHELON FLEX (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Echelon Flex powered vascular stapler has 1,877 adverse event reports on record, including 29 deaths and 259 injuries. Many reports describe the stapler failing to fire or form staples, jaws that are hard to open or get stuck in tissue, and jams, with some describing bleeding after tissue was cut without staples being placed. Reports fell to 243 in the last 12 months, from 387 in the year before. 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
- 1,880
- Deaths reported
- 29
- Injuries reported
- 256
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,880 adverse event reports that list this exact device (DI 10705036014584), received between Mar 17, 2017 and Sep 30, 2026 — classified as 29 deaths, 256 injuries, 1,595 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (714 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Fire714
- Difficult to Open or Close561
- Failure to Form Staple398
- Mechanical Jam199
- No Apparent Adverse Event194
- Adverse Event Without Identified Device or Use Problem179
- Activation Failure103
- Activation Problem51
Patient problems
- No Clinical Signs, Symptoms or Conditions1,222
- No Consequences Or Impact To Patient368
- Hemorrhage/Blood Loss/Bleeding275
- Blood Loss80
- No Code Available75
- Unspecified Tissue Injury22
- Insufficient Information21
- Failure to Anastomose16
Recent adverse event reports
The 25 most recent of 1,880 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951524 ↗MalfunctionSep 28, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919465 ↗MalfunctionSep 24, 2026Difficult to Open or Close
It was reported that, during an unknown surgery, the jaws did not open after firing. The manual override was used to return the knife and the jaws were released. There were no issues with the blood vessels. The cartridge color was White. 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 50883596 ↗MalfunctionSep 21, 2026Failure to Form Staple; Difficult to Open or Close; No Apparent Adverse Event
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50846161 ↗MalfunctionSep 21, 2026Ejection Problem; Separation Problem
It was reported that during an unknown Laparoscopic Lobectomy, the cartridge did not fit properly when tried to load the cartridge into the device. A part has come loose when the sled side of the cartridge was checked. This event was found before use. There was no effect on the patient. The cartridge color was White. 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 50842964 ↗MalfunctionSep 18, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827422 ↗MalfunctionSep 18, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826687 ↗MalfunctionSep 17, 2026Failure to Fire
It was reported that during a bedside robotic surgery firing on an appendix, it was observed that the device did not fire nor cut. Procedure was delayed due to the reported event. There is no harm to the patient and procedure was completed with the robotic stapler. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801974 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Shock
MAUDE report 50569251 ↗MalfunctionSep 2, 2026Difficult to Open or Close
It was reported that during an Unknown procedure the surgeon reports that there was speech in the opening of the mandible of the PVE35A stapler, which is part of the chest kit, after stapling, and it was necessary to replace it to proceed with the surgery. There was no harm to the patient. Was there any damage or injury reported by the patient or user? No. Was there a significant delay? Unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563206 ↗DeathAug 28, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
It was reported that the patient expired during an unspecified surgical procedure due to uterine sarcoma. According to the report, the death was considered unrelated to the devices used. The devices were reportedly used several hours prior to the patient¿s death. Additional information requested.
Patient problems: Cancer; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50500300 ↗InjuryAug 28, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem
It was reported that during an unspecified surgical procedure, it was observed that the stapler malfunctioned following application to the renal vein. According to the report, the anterior row of metallic clips failed to function correctly, resulting in significant bleeding and requiring conversion to open surgery. The current status of the patient is unknown. Additional information requested.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50500187 ↗MalfunctionAug 26, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459764 ↗MalfunctionAug 26, 2026Difficult to Open or Close; Separation Problem
It was reported that during an unspecified surgical procedure, it was observed that the reload became stuck in tissue; and could not be reopened for release. The user forced the opening of the stapler jaws without activating the safety mechanism. Issue occurred with the first reload and the device was not used again. There was no patient consequence nor surgical delay reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458849 ↗MalfunctionAug 25, 2026Difficult to Open or Close
It was reported that during an unspecified surgical procedure, the device was fired the first time perfectly and second time it fired but they then couldn't release the stapler. They had to use manual override to then release the jaw from the tissue. There was no patient consequence nor surgical delay reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50432262 ↗MalfunctionAug 20, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50354377 ↗MalfunctionAug 20, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50354375 ↗MalfunctionAug 20, 2026Failure to Cut
It was reported that, during an unknown surgery, the staple was applied, but the blood vessel had not been cut. 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 50347653 ↗MalfunctionAug 20, 2026Failure to Fire; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50347179 ↗MalfunctionAug 19, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327465 ↗MalfunctionAug 14, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260132 ↗InjuryAug 14, 2026Failure to Cut
It was reported that during a Laparoscopic Video-Assisted Thoracic Left Lower Lobectomy for lung cancer, the device was used for vessel transection. The device was used twice for PA division and the division and suturing were performed without issues. The blood vessel was taken in the jaws and fired, but at the same time, the PV was pushed outward by approximately 1¿2 mm as the staples were formed during the division of the pulmonary vein (PV). Therefore due to concerns regarding the risk of incomplete staple formation and bleeding, the jaws were opened only after ligating the proximal and distal sides with sutures. The staples had formed, but there was about 1 mm left uncut when the staple line was checked. The cartridge color was White. Additional suture was performed to complete the case. There were no adverse consequences to the patient. Additional information requested.
Patient problems: Insufficient Information
MAUDE report 50259138 ↗MalfunctionAug 10, 2026Failure to Fire
It was reported that during an unknown procedure, the Powered Vascular Stapler stopped firing after a few seconds. Reverse button used to remove from tissue. There was no patient consequence nor surgical delay reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50195004 ↗MalfunctionAug 6, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164003 ↗MalfunctionAug 3, 2026Failure to Fire; No Apparent Adverse Event
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50122196 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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