Echelon Endopath VASECR35Recalls & reported problems

Summary

The FDA's MAUDE database contains 263 adverse event reports that list this exact device (DI 10705036014591), received between Jan 24, 2018 and Sep 25, 2026 — classified as 1 death, 23 injuries, 239 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (115 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 22, 2025Open, Classified

   Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

   Z-1746-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 263 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Form Staple; No Apparent Adverse Event

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899296 ↗
• MalfunctionSep 24, 2026Difficult to Open or Close; Mechanical Jam; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883751 ↗
• MalfunctionSep 21, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847104 ↗
• MalfunctionSep 18, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829208 ↗
• MalfunctionAug 24, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410438 ↗
• MalfunctionAug 3, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122859 ↗
• MalfunctionJul 27, 2026Failure to Form Staple

  It was reported that during an unspecified surgical procedure, it was observed that the staples were malformed after firing. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046407 ↗
• MalfunctionJul 27, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019163 ↗
• MalfunctionJul 1, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND DURING STAPLING OF THE HEPATIC VEINS, THE CARTRIDGES FROM THE SAME BATCH (12 UNITS) SHOWED SIGNS OF FAILURE. THE STAPLE LINE WAS NOT COMPLETELY SEALED; CONSEQUENTLY, THE OPERATORS HAD TO REINFORCE THE STAPLE LINE WITH A NON-ABSORBABLE MONOFILAMENT SUTURE. THE CARTRIDGE BATCH WAS CHANGED.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677821 ↗
• MalfunctionJul 1, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING STAPLING OF THE HEPATIC VEINS, THE CARTRIDGES FROM THE SAME BATCH (12 UNITS) SHOWED SIGNS OF FAILURE. THE STAPLE LINE WAS NOT COMPLETELY SEALED; CONSEQUENTLY, THE OPERATORS HAD TO REINFORCE THE STAPLE LINE WITH A NON-ABSORBABLE MONOFILAMENT SUTURE. THE CARTRIDGE BATCH WAS CHANGED.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677787 ↗
• 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 25611934 ↗
• 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 25445011 ↗
• MalfunctionJun 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLER WAS ALREADY FIRED AND UP BEFORE FIRING. SO THEY CHANGED CARTRIDGE TO USE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444247 ↗
• MalfunctionJun 2, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 25365555 ↗
• MalfunctionJun 2, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 25360848 ↗
• MalfunctionJun 1, 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 25354932 ↗
• MalfunctionMay 4, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE OF THE UPPER LOBE OF THE RIGHT LUNG, AFTER A FIRE ON THE APICAL SEGMENTAL ARTERY OF THE UPPER LOBE OF THE RIGHT LUNG, THEY OBSERVED A SPRAY-LIKE BLEEDING. COMPRESSION AND CLIP WERE USED TO CONTROL THE BLEEDING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067958 ↗
• MalfunctionApr 30, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 25043719 ↗
• MalfunctionApr 21, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY PROCEDURE, THE SURGEON ATTEMPTED TO FIRE A VASCULAR STAPLER. UPON ACTIVATION, THE STAPLER DID NOT FUNCTION AS INTENDED; THE RELOAD FAILED TO DEPLOY PROPERLY. AFTER FIRING, SIGNIFICANT LEAKAGE WAS NOTED AT THE STAPLE LINE. ADDITIONALLY, ABNORMAL STAPLE FORMATION WAS OBSERVED, INDICATING A POSSIBLE DEVICE MALFUNCTION. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947123 ↗
• MalfunctionApr 16, 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 24904932 ↗
• MalfunctionApr 13, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LOBECTOMY 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 24859067 ↗
• MalfunctionApr 6, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT A FEW STAPLES WERE FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING. THEY STOPPED OOZING WITH COMPRESSION HEMOSTASIS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793973 ↗
• MalfunctionMar 10, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LUNG RESECTION 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 24561366 ↗
• MalfunctionMar 3, 2026Ejection Problem

  IT WAS REPORTED THAT DURING A PNEUMORECTOMY PROCEDURE, IT WAS OBSERVED THAT THE CARTRIDGE COULD NOT INSTALL ON THE DEVICE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496730 ↗
• MalfunctionFeb 23, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE NAIL FORMATION WAS INCOMPLETE AFTER FIRING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413955 ↗