GIARecalls & reported problems across all models
Covidien LP · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,025
- Deaths reported
- 28
- Injuries reported
- 779
- Recalls
- 0
We found 26 models of GIA by Covidien LP in the FDA's device registry (GUDID). Together they are named in 4,025 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2016 and Sep 30, 2026 — classified as 28 deaths, 779 injuries, 3,218 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (1,437 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. 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
Most reported GIA problems
Device problems
- Failure to Fire1,437
- Misfire634
- Failure to Form Staple602
- Adverse Event Without Identified Device or Use Problem469
- Detachment of Device or Device Component336
- Mechanics Altered215
- Break205
- Failure to Align127
Patient problems
- No Clinical Signs, Symptoms or Conditions1,545
- No Known Impact Or Consequence To Patient600
- No Consequences Or Impact To Patient504
- No Code Available415
- Insufficient Information296
- Tissue Breakdown277
- Failure to Anastomose262
- Unspecified Tissue Injury261
GIA models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GIA GIA8038SSTAPLE, IMPLANTABLE12 deaths1,237 reports
- GIA GIA8038LSTAPLE, IMPLANTABLE5 deaths580 reports
- GIA GIA10038SSTAPLE, IMPLANTABLE1 death456 reports
- GIA GIA6038SSTAPLE, IMPLANTABLE3 deaths319 reports
- GIA GIA80MTSSTAPLE, IMPLANTABLE1 death264 reports
- GIA GIA6038LSTAPLE, IMPLANTABLE3 deaths199 reports
- GIA GIA10038LSTAPLE, IMPLANTABLE1 death174 reports
- GIA GIA8048SSTAPLE, IMPLANTABLE169 reports
- GIA GIA80MTCSTAPLE, IMPLANTABLE164 reports
- GIA GIA10048SSTAPLE, IMPLANTABLE84 reports
- GIA GIA8048LSTAPLE, IMPLANTABLE79 reports
- GIA 030403STAPLE, IMPLANTABLE49 reports
- GIA GIA60MTSStaple, implantable1 death45 reports
- GIA GIA6025SSTAPLE, IMPLANTABLE43 reports
- GIA GIA10048LSTAPLE, IMPLANTABLE38 reports
- GIA GIA6025LSTAPLE, IMPLANTABLE31 reports
- GIA GIA60MTCStaple, implantable1 death29 reports
- GIA GIA6048LSTAPLE, IMPLANTABLE18 reports
- GIA GIA6048SSTAPLE, IMPLANTABLE16 reports
- GIA GIA80XTCSTAPLE, IMPLANTABLE12 reports
- GIA GIA80XTSSTAPLE, IMPLANTABLE11 reports
- GIA GIA60XTSStaple, implantable3 reports
- GIA GIA60TMCStapler, surgical2 reports
- GIA GIA60XTCStaple, implantable1 report
- GIA GIA60TMSStapler, surgical1 report
- GIA GIA80TMSStapler, surgical1 report
Recent 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, 2026Misfire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952459 ↗MalfunctionSep 29, 2026Failure to Form Staple
According to the reporter, during an open radical gastrectomy, when dividing the distal stomach, two staples consecutively burst out during use of the loading units. The staples did not form a proper B shape. Additionally, after the divided remnant stomach was removed, part of the middle section of the staple line had no staples. Finally, the procedure was completed by hand suturing.
Patient problems: Tissue Breakdown
MAUDE report 50935121 ↗MalfunctionSep 29, 2026Failure to Form Staple
According to the reporter, during an open radical gastrectomy, when dividing the distal stomach, two staples consecutively burst out during use of the loading units. The staples did not form a proper B shape. Additionally, after the divided remnant stomach was removed, part of the middle section of the staple line had no staples. Finally, the procedure was completed by hand suturing.
Patient problems: Tissue Breakdown
MAUDE report 50935079 ↗MalfunctionSep 29, 2026Failure to Form Staple
It was reported that after firing, the device had staple warping. The device was replaced.
Patient problems: Tissue Breakdown
MAUDE report 50934880 ↗MalfunctionSep 29, 2026Misfire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934472 ↗MalfunctionSep 23, 2026Failure to Fire
It was reported that during a procedure, the stapler got stuck. The device was replaced with a new stapler. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864979 ↗MalfunctionSep 22, 2026Failure to Fire; Component or Accessory Incompatibility
Patient problems: Insufficient Information
MAUDE report 50860175 ↗MalfunctionSep 22, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859123 ↗MalfunctionSep 21, 2026Retraction Problem
Patient problems: Insufficient Information
MAUDE report 50849016 ↗MalfunctionSep 21, 2026Misfire; Firing Problem
According to the reporter during a procedure using a manual stapler, the device was difficult to fire and the knife jammed while firing. Replaced the device of the same product to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841090 ↗MalfunctionSep 21, 2026Break; Detachment of Device or Device Component
It was reported that during a bowel obstruction case of small bowel followed by anastomosis, two stapler jaws broke and the broken jaw part disengaged. No pieces fell into the patient cavity. The device was replaced with another reload 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 50840489 ↗MalfunctionSep 21, 2026Break; Detachment of Device or Device Component
It was reported that during a bowel obstruction case of small bowel followed by anastomosis, two stapler jaws broke and the broken jaw part disengaged. No pieces fell into the patient cavity. The device was replaced with another reload 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 50840412 ↗MalfunctionSep 21, 2026Failure to Fire
It was reported that during a procedure, the stapler instrument did not fire. The device was replaced with a new product 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 50839439 ↗MalfunctionSep 18, 2026Failure to Form Staple
According to the reporter, during the procedure, the stapler had firing issues, forming an incomplete staple line at the distal end. A new device was used to complete the procedure. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819927 ↗MalfunctionSep 17, 2026Misfire
According to the reporter, during a transverse colectomy, when performing functional end-to-end (FEEA) anastomosis, when it was used for closure of the insertion hole on the fourth firing, the firing knob became too hard midway and could no longer be advanced. Upon confirmation, forceps and the like were not caught inside. Hence, it could not be advanced; the firing knob was returned. To resolve the issue, a new stapler and cartridge were taken out and used, and resection was performed.
Patient problems: Failure to Anastomose
MAUDE report 50807323 ↗
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
- EEA39 models · 4,432 reports · 1 recall
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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