Endo GIARecalls & reported problems across all models
Covidien LP · 48 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26,277
- Deaths reported
- 71
- Injuries reported
- 3,377
- Recalls
- 8
We found 48 models of Endo GIA by Covidien LP in the FDA's device registry (GUDID). Together they are named in 26,277 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2016 and Sep 30, 2026 — classified as 71 deaths, 3,377 injuries, 22,828 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (12,118 reports).
8 FDA recall records name at least one of these models by its device identifier.
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
Reports received per month, all models
Endo GIA 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.
- Apr 26, 2018Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Z-1822-2018 · Root cause: Process control · Recall details · FDA record ↗
- Apr 26, 2018Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Z-1820-2018 · Root cause: Process control · Recall details · FDA record ↗
- Apr 26, 2018Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Z-1819-2018 · Root cause: Process control · Recall details · FDA record ↗
- Apr 26, 2018Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Z-1818-2018 · Root cause: Process control · Recall details · FDA record ↗
- Apr 26, 2018Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Z-1817-2018 · Root cause: Process control · Recall details · FDA record ↗
- Apr 26, 2018Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Z-1816-2018 · Root cause: Process control · Recall details · FDA record ↗
- Apr 26, 2018Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Z-1815-2018 · Root cause: Process control · Recall details · FDA record ↗
- Apr 26, 2018Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Z-1814-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported Endo GIA problems
Device problems
- Failure to Fire12,118
- Failure to Form Staple4,783
- Misfire3,936
- Difficult to Open or Close2,779
- Adverse Event Without Identified Device or Use Problem2,243
- Entrapment of Device1,383
- Break1,320
- Human-Device Interface Problem1,044
Patient problems
- No Clinical Signs, Symptoms or Conditions9,671
- No Known Impact Or Consequence To Patient5,336
- No Consequences Or Impact To Patient4,960
- No Code Available1,697
- Tissue Breakdown1,614
- Insufficient Information1,390
- Unspecified Tissue Injury1,389
- Hemorrhage/Blood Loss/Bleeding1,107
Endo GIA models
48 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Endo GIA EGIA60AMTSTAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA EGIA45AMTSTAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA EGIA45AVMSTAPLE, IMPLANTABLE7 deaths1,583 reports
- Endo GIA EGIA60AVMSTAPLE, IMPLANTABLE9 deaths1,438 reports
- Endo GIA 030458STAPLE, IMPLANTABLE1 recall1 death948 reports
- Endo GIA EGIA60AXTSTAPLE, IMPLANTABLE4 deaths987 reports
- Endo GIA 030415STAPLE, IMPLANTABLE973 reports
- Endo GIA 030449STAPLE, IMPLANTABLE2 deaths716 reports
- Endo GIA 030459STAPLE, IMPLANTABLE1 death651 reports
- Endo GIA 030414STAPLE, IMPLANTABLE1 death648 reports
- Endo GIA EGIA45CTAVMSTAPLE, IMPLANTABLE2 deaths405 reports
- Endo GIA 030455STAPLE, IMPLANTABLE1 recall1 death324 reports
- Endo GIA EGIA30CTAVMSTAPLE, IMPLANTABLE1 death351 reports
- Endo GIA 030456STAPLE, IMPLANTABLE337 reports
- Endo GIA 030454STAPLE, IMPLANTABLE1 recall5 deaths252 reports
- Endo GIA EGIATRS60AMTSTAPLE, IMPLANTABLE2 deaths274 reports
- Endo GIA EGIA45AXTSTAPLE, IMPLANTABLE225 reports
- Endo GIA EGIATRS60AXTSTAPLE, IMPLANTABLE221 reports
- Endo GIA EGIAADAPTSTAPLE, IMPLANTABLE208 reports
- Endo GIA 030457STAPLE, IMPLANTABLE1 recall145 reports
- Endo GIA 030422STAPLE, IMPLANTABLE177 reports
- Endo GIA EGIARADMTSTAPLE, IMPLANTABLE168 reports
- Endo GIA 030451STAPLE, IMPLANTABLE1 recall109 reports
- Endo GIA 030423STAPLE, IMPLANTABLE142 reports
- Endo GIA 030425STAPLE, IMPLANTABLE140 reports
- Endo GIA EGIA60CTAMTSTAPLE, IMPLANTABLE126 reports
- Endo GIA EGIAUNIVXLSTAPLE, IMPLANTABLE106 reports
- Endo GIA EGIA30AVMSTAPLE, IMPLANTABLE2 deaths93 reports
- Endo GIA 030452STAPLE, IMPLANTABLE1 recall38 reports
- Endo GIA EGIA45CTAMTSTAPLE, IMPLANTABLE85 reports
- Endo GIA EGIA45CTAVSTAPLE, IMPLANTABLE77 reports
- Endo GIA EGIA30AVSTAPLE, IMPLANTABLE1 recall17 reports
- Endo GIA 030450STAPLE, IMPLANTABLE1 recall17 reports
- Endo GIA 030412STAPLE, IMPLANTABLE2 deaths67 reports
- Endo GIA EGIARADXTSTAPLE, IMPLANTABLE65 reports
- Endo GIA 030419STAPLE, IMPLANTABLE58 reports
- Endo GIA EGIA45AVSTAPLE, IMPLANTABLE58 reports
- Endo GIA EGIATRS45AMTSTAPLE, IMPLANTABLE57 reports
- Endo GIA EGIATRS45AXTSTAPLE, IMPLANTABLE57 reports
- Endo GIA EGIA45AMTStaple, implantable53 reports
- Endo GIA EGIA60CTAVMSTAPLE, IMPLANTABLE48 reports
- Endo GIA EGIA30AMTSTAPLE, IMPLANTABLE47 reports
- Endo GIA EGIAADAPTXLSTAPLE, IMPLANTABLE44 reports
- Endo GIA 030418STAPLE, IMPLANTABLE1 death40 reports
- Endo GIA EGIA30CTAVSTAPLE, IMPLANTABLE32 reports
- Endo GIA 030453STAPLE, IMPLANTABLE1 death18 reports
- Endo GIA 030426STAPLE, IMPLANTABLE4 reports
- Endo GIA 030416STAPLE, IMPLANTABLE3 reports
Recent Endo GIA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952420 ↗MalfunctionSep 30, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952320 ↗MalfunctionSep 30, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950140 ↗MalfunctionSep 29, 2026Break; Misfire; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941198 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941030 ↗MalfunctionSep 29, 2026Failure to Form Staple
Patient problems: Tissue Breakdown
MAUDE report 50937332 ↗MalfunctionSep 29, 2026Human-Device Interface Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937174 ↗MalfunctionSep 29, 2026Failure to Form Staple
Patient problems: Tissue Breakdown
MAUDE report 50937140 ↗MalfunctionSep 29, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936995 ↗MalfunctionSep 29, 2026Mechanics Altered
Patient problems: Tissue Breakdown
MAUDE report 50936740 ↗MalfunctionSep 29, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936622 ↗MalfunctionSep 29, 2026Break; Failure to Fire
It was reported that during anterior resection of rectum, once the reload was loaded and inserted through the trocar, it could not be activated. After several attempts, it was removed. A small metal tab was protruding from the side of the reload and was not visible on a new reload.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935016 ↗MalfunctionSep 29, 2026Misfire
It was reported during a procedure that, after firing approximately half of the reload, the remaining portion failed to fire. To resolve the issue, a competitor's manual stapler was used to complete the procedure. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934685 ↗MalfunctionSep 29, 2026Misfire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934559 ↗MalfunctionSep 29, 2026Misfire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934209 ↗
Other Covidien LP products
- 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
- EEA39 models · 4,432 reports · 1 recall
- Puritan Bennett119 models · 3,169 reports · 18 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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