EEA EEA25Recalls & reported problems

Summary

The FDA's MAUDE database contains 406 adverse event reports that list this exact device (DI 10884523004731), received between Feb 2, 2016 and Sep 30, 2026 — classified as 3 deaths, 142 injuries, 261 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (101 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. May 13, 2022Open, Classified

   The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.

   Z-1322-2022 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 406 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  It was reported during a procedure that after firing, the circular stapler produced an incomplete staple line and the line did not bite properly. The device was replaced to resolve the issue. their was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947784 ↗
• MalfunctionSep 29, 2026Break

  It was reported that during a laparoscopic low anterior resection procedure, a circular stapler experienced the anvil cap was damaged. To resolve the issue another stapler was used to complete the procedure. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935419 ↗
• MalfunctionAug 12, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224430 ↗
• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224122 ↗
• MalfunctionAug 6, 2026Misfire; Failure to Form Staple

  Patient problems: Failure to Anastomose

  MAUDE report 50167803 ↗
• MalfunctionAug 6, 2026Misfire

  According to the reporter, during a radical rectal cancer surgery, when the chief surgeon used an end-to-end anastomosis stapler, the green indicator band was not visible when rotating the wing nut. A new stapler of the same model was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50154348 ↗
• InjuryJul 31, 2026Failure to Form Staple; Human-Device Interface Problem

  It was reported that during an esophagectomy, a single use stapler was difficult or unable to close during set-up as the white safety tab was stuck. It was also reported that, during firing, there was an incomplete staple line with partial firing. It was reported that the issue was addressed by hand sewing and converting the procedure from minimally invasive surgery to an open approach.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 50107820 ↗
• MalfunctionApr 3, 2026Difficult to Remove; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL GASTRECTOMY PROCEDURE, WHEN IT WAS APPLIED TO THE INTESTINE, AFTER THE DEVICE COMPLETED ITS FULL FIRING CYCLE, SOME STAPLES WERE OBSERVED TO BE MALFORMED. THE INSTRUMENT HANDLE WAS REPORTED TO HAVE BEEN FULLY SQUEEZED, THE DONUTS WERE REPORTED TO BE COMPLETE, AND THE ANVIL COULD NOT BE TILTED AFTER FIRING. THE STAPLE LINE WAS REPAIRED BY OVERSEWING, THE DEVICE WAS REPLACED TO COMPLETE THE CASE.

  Patient problems: Failure to Anastomose

  MAUDE report 24783720 ↗
• MalfunctionApr 2, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC CANCER SURGERY INVOLVING GASTRIC-ESOPHAGEAL ANASTOMOSIS, SOME OF THE STAPLES WERE INCOMPLETELY FORMED. THE DEVICE REQUIRED REPLACEMENT WITH A NEW CIRCULAR STAPLER, AND RE-RESECTION AND RE-ANASTOMOSIS WERE PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24769536 ↗
• MalfunctionMar 31, 2026Failure to Fire; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY WITH ESOPHAGOJEJUNAL ANASTOMOSIS, WHILE PERFORMING THE ANASTOMOSIS, THE INSTRUMENT DID NOT FIRE STAPLES. THERE WAS DIFFICULTY WITH THE SAFETY LEVER, AND THE HANDLE WAS NOT FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE AND USING ANOTHER CIRCULAR STAPLER FOR THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747265 ↗
• MalfunctionMar 11, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW RECTAL CANCER RESECTION PROCEDURE, THE DEVICE WAS APPLIED FOR GASTROINTESTINAL ANASTOMOSIS AND DID NOT FIRE. THE SPACE BETWEEN THE CARTRIDGE AND ANVIL WAS CLOSED, AND THE GREEN BAR WAS VISIBLE IN THE INDICATOR WINDOW, BUT THE STAPLER DID NOT FUNCTION AT ALL. THE DEVICE WAS REPLACED WITH A NEW CIRCULAR STAPLER TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575546 ↗
• MalfunctionMar 9, 2026Misfire

  ACCORDING TO THE REPORTER, THE DEVICE WAS DEFECTIVE DURING INTERVENTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552962 ↗
• MalfunctionMar 9, 2026Misfire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DEVICE WAS DEFECTIVE DURING INTERVENTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552961 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS A POSTOPERATIVE PARTIAL ANASTOMOTIC FISTULA.

  Patient problems: Fistula

  MAUDE report 24552951 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS A POSTOPERATIVE PARTIAL ANASTOMOTIC FISTULA.

  Patient problems: Fistula

  MAUDE report 24552944 ↗
• DeathMar 9, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS A POSTOPERATIVE ANASTOMOTIC FAILURE THAT CAUSED POSTOPERATIVE MORTALITY.

  Patient problems: Failure to Anastomose

  MAUDE report 24552928 ↗
• DeathMar 9, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS A POSTOPERATIVE ANASTOMOTIC FAILURE THAT CAUSED POSTOPERATIVE MORTALITY.

  Patient problems: Failure to Anastomose

  MAUDE report 24552851 ↗
• MalfunctionMar 2, 2026Device Slipped

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION OF THE RECTUM, THE STAPLER WAS DIFFICULT OR UNABLE TO CLOSE. IT WAS ALSO NOTED THAT UNUSUAL EFFORT WAS REQUIRED TO TURN THE TWIST KNOB IN ORDER TO VISUALIZE THE GREEN BAR. A DIFFERENT PRODUCT WAS USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491455 ↗
• MalfunctionFeb 27, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE CIRCULAR STAPLER WAS USED TO STAPLE THE TRANSVERSE COLON AND THE RIGHT SIDE OF THE COLON. AFTER FIRING, THE STAPLE LEG HEIGHT WAS FOUND TO BE TOO HIGH, RESULTING IN POOR ANASTOMOSIS. WITH SUTURES, THE EDGES WERE OVERLOCKED AND ADDITIONAL SEAMS WERE ADDED.

  Patient problems: Failure to Anastomose

  MAUDE report 24476477 ↗
• MalfunctionFeb 27, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN ESOPHAGECTOMY PROCEDURE, WHILE PERFORMING THE ANASTOMOSIS OF THE STOMACH AND ESOPHAGUS, THERE WAS INCOMPLETE STAPLE LINE. THE DEVICE WAS REPLACED WITH ANOTHER STAPLER OF THE SAME TYPE TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE.

  Patient problems: Tissue Breakdown

  MAUDE report 24472287 ↗
• MalfunctionFeb 11, 2026Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC COLECTOMY, WHEN ON JEJUNAL ANASTOMOSIS, THE STAPLER PARTIALLY FIRED. ADDITIONALLY, THE ANVIL DID NOT TILT AFTER FIRING. A NEW CIRCULAR STAPLER WAS USED INSTEAD TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Failure to Anastomose

  MAUDE report 24318518 ↗
• MalfunctionDec 26, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC DIGESTIVE TRACT ANASTOMOSIS PROCEDURE, THE CIRCULAR STAPLER DID NOT FIRE WHEN APPLIED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895582 ↗
• MalfunctionDec 22, 2025Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTROTOMY, THERE WAS A STAPLE FORMATION ISSUE, AND INCOMPLETE DONUT FORMATION. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23866390 ↗
• MalfunctionDec 10, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW RECTAL CANCER RESECTION PROCEDURE, SOME STAPLES WERE POORLY FORMED. TO RESOLVE THE ISSUE, THE SURGEON HAD TO OVERSEW. IT WAS NOTED THAT THE OPERATION TIME WAS PROLONGED BY LESS THAN 30 MINUTES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23771002 ↗
• MalfunctionDec 3, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL CANCER SURGERY, WHEN CUTTING AND CLOSING THE RECTUM, THE HANDLE COULD NOT BE PRESSED, AND THE DEVICE DID NOT FIRE. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707201 ↗