EEARecalls & reported problems across all models

We found 39 models of EEA by Covidien LP in the FDA's device registry (GUDID). Together they are named in 4,432 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2016 and Sep 30, 2026 — classified as 29 deaths, 1,855 injuries, 2,548 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (1,143 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EEA recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported EEA problems

EEA models

39 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EEA EEA28

  STAPLE, IMPLANTABLE
  6 deaths992 reports
• EEA EEA31

  STAPLE, IMPLANTABLE
  4 deaths543 reports
• EEA TRIEEA28MT

  STAPLE, IMPLANTABLE
  4 deaths511 reports
• EEA EEA25

  STAPLE, IMPLANTABLE
  1 recall3 deaths406 reports
• EEA HEM3335

  STAPLE, IMPLANTABLE
  247 reports
• EEA EEAXL2535

  STAPLE, IMPLANTABLE
  1 death232 reports
• EEA TRIEEA28XT

  Stapler, surgical
  220 reports
• EEA EEAXL25

  STAPLE, IMPLANTABLE
  1 recall5 deaths152 reports
• EEA TRIEEA31MT

  STAPLE, IMPLANTABLE
  2 deaths186 reports
• EEA EEA33

  STAPLE, IMPLANTABLE
  3 deaths128 reports
• EEA EEA2535

  STAPLE, IMPLANTABLE
  125 reports
• EEA HEM3348

  STAPLE, IMPLANTABLE
  90 reports
• EEA EEA2835

  STAPLE, IMPLANTABLE
  1 death89 reports
• EEA EEAXL28

  STAPLE, IMPLANTABLE
  89 reports
• EEA TRIEEA31XT

  Stapler, surgical
  73 reports
• EEA EEA21

  STAPLE, IMPLANTABLE
  48 reports
• EEA TRIEEA25MT

  Staple, implantable
  46 reports
• EEA EEAXL31

  STAPLE, IMPLANTABLE
  45 reports
• EEA EEAXL2135

  STAPLE, IMPLANTABLE
  36 reports
• EEA TRIEEAXL28XT

  Stapler, surgical
  28 reports
• EEA TRIEEAXL28MT

  Staple, implantable
  22 reports
• EEA EEAXL2835

  STAPLE, IMPLANTABLE
  21 reports
• EEA EEA2135

  STAPLE, IMPLANTABLE
  15 reports
• EEA EEAXL21

  STAPLE, IMPLANTABLE
  13 reports
• EEA EEATAID25D

  Guide, surgical, instrument
  13 reports
• EEA TRIEEAXL25XT

  Staple, implantable
  8 reports
• EEA TRIEEA33XT

  Stapler, surgical
  7 reports
• EEA TRIEEAXL25MT

  Staple, implantable
  7 reports
• EEA TRIEEAXL31XT

  Stapler, surgical
  7 reports
• EEA TRIEEA33MT

  Staple, implantable
  6 reports
• EEA TRIEEA25XT

  Staple, implantable
  5 reports
• EEA TRIEEA21MT

  Stapler, surgical
  4 reports
• EEA EEAXL33

  STAPLE, IMPLANTABLE
  4 reports
• EEA TRIEEAXL21MT

  Staple, implantable
  3 reports
• EEA TRIEEAXL31MT

  Staple, implantable
  3 reports
• EEA TRIEEAXL25XTORVIL

  Staple, implantable
  3 reports
• EEA 020250

  SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
  2 reports
• EEA TRIEEAXL25MTORVIL

  Staple, implantable
  2 reports
• EEA TRIEEAXL33XT

  Stapler, surgical
  1 report

Recent EEA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951331 ↗
• MalfunctionSep 30, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950953 ↗
• 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 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that four days postoperatively, an atypical anastomotic leak occurred. No intraoperative issues were reported; the tissue donuts were reported as fine, with no abnormal tissue or tension observed. Additional surgery was performed.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 50937283 ↗
• MalfunctionSep 29, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  It was reported that during an end-to-end anastomosis procedure, holes were discovered during the air leak test. The device was replaced to resolve the issue and the surgical time was extended.

  Patient problems: Failure to Anastomose

  MAUDE report 50936711 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose

  MAUDE report 50935454 ↗
• 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 ↗
• MalfunctionSep 23, 2026Failure to Form Staple

  It was reported that, after successful firing of the single-use stapler during an implant procedure, the staple line was incomplete and did not bite properly. A new device was used to resolve the issue.

  Patient problems: Failure to Anastomose

  MAUDE report 50863491 ↗
• MalfunctionSep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose

  MAUDE report 50859907 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  According to the reporter, intra-operatively, the air leak test was positive after firing the stapler requiring a laparoscopic suture repair and diverting stoma.

  Patient problems: Failure to Anastomose

  MAUDE report 50842647 ↗
• MalfunctionSep 21, 2026Break

  According to the reporter, during a procedure, the safety lock of the circular stapler broke. 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 50841927 ↗
• MalfunctionSep 21, 2026Misfire

  It was reported that after successful firing of the circular Stapler, an issue involving the purstring device occurred. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839265 ↗
• MalfunctionSep 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829223 ↗
• MalfunctionSep 16, 2026Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50788887 ↗
• MalfunctionSep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose

  MAUDE report 50782029 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• Puritan Bennett119 models · 3,169 reports · 18 recalls