SigniaRecalls & reported problems across all models

We found 16 models of Signia by Covidien LP in the FDA's device registry (GUDID). Together they are named in 8,201 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2016 and Sep 30, 2026 — classified as 7 deaths, 522 injuries, 7,671 malfunctions.

The most frequently reported specific device problem is “Misfire” (1,618 reports).

6 FDA recall records name at least one of these models by its device identifier, 2 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

Signia 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. Sep 25, 2025Open, Classified

   A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.

   Z-0485-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Feb 14, 2024Open, Classified

   Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.

   Z-1457-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Mar 4, 2021Terminated

   Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.

   Z-1385-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Mar 4, 2021Terminated

   Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.

   Z-1384-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Mar 4, 2021Terminated

   Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.

   Z-1383-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Dec 13, 2017Terminated

   Product reportedly shutting down during use.

   Z-1237-2018 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported Signia problems

Signia models

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

• Signia SIGPHANDLE

  STAPLE, IMPLANTABLE
  1 recall3 deaths5,356 reports
• Signia SIGADAPTSTND

  STAPLE, IMPLANTABLE
  1 death1,431 reports
• Signia SIGADAPTXL

  STAPLE, IMPLANTABLE
  452 reports
• Signia SIGADAPTSHORT

  STAPLE, IMPLANTABLE
  284 reports
• Signia SIGSDS30CTVT

  Staple, implantable
  2 recalls1 death152 reports
• Signia SIGPSHELL

  STAPLE, IMPLANTABLE
  1 death227 reports
• Signia SIGSDS30CTV

  Staple, implantable
  1 recall1 death80 reports
• Signia SIGSDL45CTVT

  Staple, implantable
  2 recalls27 reports
• Signia SIGLU60A

  STAPLE, IMPLANTABLE
  81 reports
• Signia SIGSBCHGR

  STAPLE, IMPLANTABLE
  47 reports
• Signia SIGMRET

  STAPLE, IMPLANTABLE
  30 reports
• Signia SIGPHANDLE-RFB

  Staple, implantable
  13 reports
• Signia SIGCIRXL

  Stapler, surgical
  10 reports
• Signia SIGLU45A

  STAPLE, IMPLANTABLE
  7 reports
• Signia SIGCIRSTND

  Staple, implantable
  3 reports
• Signia SIGRIG

  STAPLE, IMPLANTABLE
  1 report

Recent Signia adverse event reports

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

• MalfunctionSep 30, 2026No Display/Image; Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952505 ↗
• MalfunctionSep 29, 2026Self-Activation or Keying

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937333 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937104 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936651 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936418 ↗
• MalfunctionSep 29, 2026Misfire

  According to the reporter, during a low anterior resection, at the time of rectal resection, partial firing occurred. Firing stopped at 1 cm site. The reload was replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929215 ↗
• MalfunctionSep 28, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924343 ↗
• MalfunctionSep 28, 2026Battery Problem; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924261 ↗
• MalfunctionSep 24, 2026Misfire

  It was reported that during a gastric bypass procedure, the surgeon positioned the stapler on the tissue to create the gastric pouch. Upon the third firing, after noting that the indicator read "1", the surgeon began to fire, but midway through the firing, the tissue began to bunch up, the staples started to deform, and the blade failed to advance. The issue was managed by resecting and re-stapling the tissue.

  Patient problems: Tissue Breakdown

  MAUDE report 50877034 ↗
• MalfunctionSep 24, 2026Misfire

  It was reported that during a gastric bypass procedure, the surgeon positioned the stapler on the tissue to create the gastric pouch. Upon the third firing, after noting that the indicator read "1", the surgeon began to fire, but midway through the firing, the tissue began to bunch up, the staples started to deform, and the blade failed to advance. The issue was managed by resecting and re-stapling the tissue.

  Patient problems: Tissue Breakdown

  MAUDE report 50877012 ↗
• MalfunctionSep 23, 2026Misfire

  It was reported that during an open colon resection, partial firing had occurred. The firing stopped once staples reached the tissue. The power handle was replaced after the multiple failed reloads. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863659 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that during a robotic-assisted left colectomy, the device was fired and the screen showed the anvil was tilting before removal. After removal, the device was examined and the reload had become detached from the adapter. The reload came off as the integrated trocar extended and prevented the anvil from tilting. After troubleshooting, the reload was able to be returned to the adapter and allowed the anvil to tilt normally. No patient harm or complications. After the case, the adapter and handle were tested with a fresh reload without any issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863531 ↗
• MalfunctionSep 22, 2026Device Slipped; Device Displays Incorrect Message

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860374 ↗
• MalfunctionSep 22, 2026Device Slipped; Device Displays Incorrect Message

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860365 ↗
• MalfunctionSep 22, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860149 ↗

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
• 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