Tri-Staple 2.0 SIGRADMTRecalls & reported problems
Covidien LP · Radial Intelligent Reload · Class 2 · Implant
All models of Tri-Staple 2.0 (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Tri-Staple radial stapler reload has 118 adverse event reports, with 22 injuries and no deaths. Most describe the stapler failing to fire or misfiring, and some describe reloads that were hard to open or close. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 118
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 10884521543768), received between Apr 19, 2018 and Jul 7, 2026 — classified as 22 injuries, 96 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (47 reports).
14 other recalls cover devices cleared under the same FDA submission (K160176); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Fire47
- Misfire43
- Difficult to Open or Close12
- Failure to Form Staple10
- Entrapment of Device7
- Adverse Event Without Identified Device or Use Problem6
- Break6
- Expulsion5
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- No Consequences Or Impact To Patient32
- No Code Available14
- Tissue Damage11
- Unspecified Tissue Injury6
- Insufficient Information5
- Failure to Anastomose3
- Injury3
Recent adverse event reports
The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2026Failure to Fire
ACCORDING TO THE REPORTER, DURING THE ESOPHAGECTOMY, WHILE AT THE GASTRIC TUBE CREATION, FIRING COULD NOT BE PERFORMED AT ALL. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25741580 ↗MalfunctionFeb 17, 2026Device Displays Incorrect Message
ACCORDING TO THE REPORTER, PRIOR TO USE, AN EXCESSIVE FORCE ERROR WAS DISPLAYED ON THE POWERED HANDLE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364792 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY INVESTIGATED IF THERE WAS ANY ASSOCIATION BETWEEN QUANTITATIVE BLOOD FLOW AT THE PLANNED ANASTOMOTIC SITE AND THE INCIDENCE OF ANASTOMOTIC LEAKAGE IN PATIENTS UNDERGOING SUBTOTAL ESOPHAGECTOMY WITH GASTRIC CONDUIT RECONSTRUCTION. THE GASTRIC CONDUIT WAS FORMED WITH AN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY AND SEQUENTIAL APPLICATIONS OF LINEAR ENDO GIA TRI-STAPLE TECHNOLOGY STAPLERS. THERE WERE 100 PATIENTS ENROLLED FROM (B)(6) 2023 TO (B)(6) 2024. OF THOSE PATIENTS 9 HAD ANASTOMOTIC LEAKAGE, 1 HAD NECROSIS OF THE GASTRIC CONDUIT, AND 9 PATIENTS HAD SURGICAL SITE INFECTIONS. NEW QUANTITATIVE BLOOD FLOW ASSESSMENT OF GASTRIC CONDUIT WITH INDOCYANINE GREEN FLUORESCENCE IN OESOPHAGECTOMY: PROSPECTIVE COHORT STUDY: DAISUKE KAJIYAM. BJS OPEN, 2025, ZRAF135. 2025.
Patient problems: Necrosis; Unspecified Infection
MAUDE report 24246241 ↗MalfunctionOct 29, 2025Break; Failure to Read Input Signal; Misfire; Break; Failure to Read Input Signal; Misfire
ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PARTIAL LUNG RESECTION, PRIOR TO LUNG PARENCHYMA RESECTION, THE POWERED HANDLE DID NOT RECOGNIZE THE RELOAD. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE RELOAD WAS PARTIALLY FIRED AND THE INTERLOCK WAS ENGAGED. THE CLAMPING MECHANISM WAS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415130 ↗MalfunctionAug 25, 2025Misfire; Difficult to Open or Close; Misfire; Difficult to Open or Close
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC COLORECTAL RESECTION, THE STAPLES INITIALLY FIRED BUT THEN IT COULD NOT CONTINUE TO BE FIRED SUCCESSFULLY AS THE HANDLE WOULD NOT CLOSE SUFFICIENTLY AND RESULTED IN THE CRACKING SOUND BEING GENERATED AND NO FURTHER STAPLING BEING ALLOWED TO COMPLETE THE RELOAD CAPABILITY. THE ISSUE WAS RESOLVED WHEN A NEW HANDLE AND RELOAD WERE OPENED AND USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22890668 ↗MalfunctionAug 15, 2025Misfire; Noise, Audible; Misfire; Noise, Audible
ACCORDING TO THE REPORTER, DURING PULMONARY PARENCHYMA THORACOSCOPIC PARTIAL PULMONARY RESECTION, WHEN THE DEVICE REACHED ABOUT HALF OF ITS TOTAL LENGTH, A CRACKING SOUND WAS HEARD, AND THE FIRING COULD NOT BE COMPLETED. WHEN THE HANDLE WAS RETURNED/PUT BACK, IT RESULTED IN PARTIALLY INCOMPLETE STAPLING. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22813315 ↗MalfunctionAug 4, 2025Misfire; Misfire
ACCORDING TO THE REPORTER, DURING THE PARTIAL RESECTION OF THE INTERSTITIAL PNEUMONIA, WHEN APPLIED ON THE LUNG, WHILE USING THE 12MM. RADIAL RELOAD, THE FIRING STOPPED AT MIDWAY. THE RELOAD WAS CHANGED TO 15MM. RADIAL RELOAD AND THE FIRING COULD BE DONE. IT WAS NOTED THAT THERE WAS A TEAR OR RUPTURE NEAR THE STAPLE LINE, SO ADDITIONAL MANUAL SUTURING WAS PERFORMED.
Patient problems: Tissue Breakdown
MAUDE report 22709383 ↗MalfunctionMar 14, 2025Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER DURING A SIGMOID COLECTOMY, THE FIRING COULD NOT BE DONE AT ALL. A NEW HANDLE AND RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604160 ↗MalfunctionOct 21, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A PULMONARY RESECTION, WHEN THE PRODUCT WAS ATTACHED TO THE RESECTION FOR REMOVAL OF THE PULMONARY PARENCHYMA, IT COULD BE CLAMPED BUT THE FIRING COULD NOT BE DONE. ANOTHER LOT OF RADIAL RELOAD WAS USED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE SAME HANDLE WAS USED TO THE NEW RELOAD. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20494442 ↗MalfunctionOct 18, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING THE ROBOT-ASSISTED LOWER ESOPHAGEAL CANCER SURGERY, WHILE ON GASTRIC TUBE RECONSTRUCTION, ONE OF THE 12MM. RADIAL RELOAD FELT DIFFERENT FROM NORMAL WHEN CHECKING WHETHER IT WAS OPEN OR CLOSED. AFTER THAT, THE FIRING COULD NOT BE DONE, SO A NEW RELOAD WAS OPENED. THE 2ND 12MM. RADIAL RELOAD WAS CONNECTED TO THE HANDLE BUT THE SHIPPING WEDGE COULD NOT BE REMOVED. A THIRD RADIAL RELOAD WAS USED AND ABLE TO FIRE WITHOUT ANY PROBLEMS. ADDITIONALLY, FIVE 60MM. PURPLE RELOADS WERE USED BUT ONE OF THE RELOAD CONTAINED WHAT APPEARED TO BE DIRT SO THE USAGE WAS DISCONTINUED. A NEW RELOAD WAS OPENED AND THE PROCEDURE WAS CONTINUED. DURING THORACIC CAVITY MANIPULATION, OTHER RELOADS COULD BE FIRED WITH THE SAME MANUAL HANDLE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482335 ↗MalfunctionOct 15, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PARTIAL LUNG RESECTION, THE FIRING COULD NOT BE DONE AT ALL. IT WAS NOTED THAT THE JAWS WERE COMPLETELY CLOSED, AND THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. ANOTHER CARTRIDGE WAS REPLACED, AND THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20452787 ↗MalfunctionSep 13, 2024Misfire; Misfire
ACCORDING TO THE REPORTER, DURING A GASTRECTOMY, AT THE START OF THE PROCEDURE, THE FIRING STOPPED AROUND THE CENTER. THE KNIFE BLADE WAS RETRACTED, AND A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20216556 ↗MalfunctionJul 12, 2024Break; Noise, Audible; Break; Noise, Audible
ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION (LAR), ON DIVISION OF THE BOWEL, THE INSTRUMENT BROKE. SUTURING WAS DONE AS A STAPLE LINE REINFORCEMENT. THE SURGEON HAD TO OVER SEW THE STAPLE LINE SO THE TIME OF THE PROCEDURE WAS EXTENDED, WITHOUT A GIVEN TIME FRAME.
Patient problems: Tissue Breakdown
MAUDE report 19735512 ↗MalfunctionMay 23, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LEFT UPPER LOBECTOMY, DURING LUNG RESECTION, AFTER FIRING THREE PURPLE RELOAD, THE SURGEON USED A SECOND MANUAL HANDLE AND TWO PURPLE RELOADS, HOWEVER AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZE AND THE DEVICE DID NOT FIRE. A THIRD 45M BLACK RELOAD WAS TAKEN OUT, AND DURING IN THE MIDDLE OF THE FIRING, THE HANDLE COULD NOT BE SQUEEZE AGAIN AFTER PRESSING THE GREEN BUTTON. A FOURTH CARTRIDGE WAS ABLE TO BE FIRED. WHEN THE THREE CARTRIDGE WAS CHECKED, IT WAS IN PRE-FIRED STATE. THE SURGEON REPORTED THAT THERE WAS A LOUD BANG WHEN THE HANDLE WAS SQUEEZED BUT UNSURE WHICH HANDLE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19387505 ↗MalfunctionMay 23, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LEFT UPPER LOBECTOMY, DURING LUNG RESECTION, AFTER FIRING THREE PURPLE RELOAD, THE SURGEON USED A SECOND MANUAL HANDLE AND TWO PURPLE RELOADS, HOWEVER AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZE AND THE DEVICE DID NOT FIRE. A THIRD 45M BLACK RELOAD WAS TAKEN OUT, AND DURING IN THE MIDDLE OF THE FIRING, THE HANDLE COULD NOT BE SQUEEZE AGAIN AFTER PRESSING THE GREEN BUTTON. A FOURTH CARTRIDGE WAS ABLE TO BE FIRED. WHEN THE THREE CARTRIDGE WAS CHECKED, IT WAS IN PRE-FIRED STATE. THE SURGEON REPORTED THAT THERE WAS A LOUD BANG WHEN THE HANDLE WAS SQUEEZED BUT UNSURE WHICH HANDLE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19387451 ↗MalfunctionMay 23, 2024Misfire; Mechanics Altered; Misfire; Mechanics Altered
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMA (SIGMOID) RESECTION, WHEN DISSECTING THE SIGMA, THE SURGEON PLACED THE RELOAD IN ITS PLACE, AND WHEN CLOSING THE JAWS, THE DEVICE MADE A LOUD CRACKING NOISE. THE SURGEON THEN DID NOT USE THE DEVICE. TO RESOLVE THE ISSUE, ANOTHER HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY. MEDTRONIC'S EVALUATION FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19386467 ↗MalfunctionNov 30, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC ESOPHAGECTOMY, THE DEVICE WAS USED FOR ESOPHAGEAL RESECTION AND AZYGOS VEIN RESECTION WITHOUT ANY PROBLEMS. HOWEVER, WHEN THE STOMACH WAS RESECTED WITH A RADIAL RELOAD DURING GASTRIC TUBE CREATION, THE GREEN BUTTON WAS PRESSED, BUT THE HANDLE COULD NOT BE SQUEEZED. THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18243327 ↗MalfunctionSep 27, 2023Break; Misfire; Difficult to Open or Close; Break; Misfire; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CUTTING RECTUM, THERE WAS INCOMPLETE GRASPING OF A NEW CLIP AND STAPLE; CLAMP DID NOT CLOSE PROPERLY, SO IT WAS BROKEN AND STAPLING IN HALF (INCOMPLETE STAPLING). THERE WERE TWO RELOADS AND ONE HANDLE INVOLVED. A THIRD RELOAD AND A NEW HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17830537 ↗MalfunctionSep 19, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL PULMONARY RESECTION PROCEDURE, WHILE AT PULMONARY PARENCHYMA, STAPLER WAS USED AND WHEN FIRING WAS ATTEMPTED, FIRING COULD NOT TO BE DONE. A NEW RELOAD WAS USED WITH THE SAME HANDLE AND ADAPTER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17775624 ↗MalfunctionSep 8, 2023Misfire; Misfire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY) ESOPHAGECTOMY, AT THE TIME OF THE FIRST FIRING DURING GASTRIC TUBE CREATION (GASTRECTOMY), ONLY TWO TO THREE STAPLES WERE FIRED ON THE TISSUE. WHEN THE PRODUCT WAS CHECKED, THERE WAS EVIDENCE THAT FIRING STOPPED HALFWAY THROUGH THE FIRING. A NEW RELOAD WAS OPENED AND USED WITH THE SAME POWERED DEVICES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17714198 ↗MalfunctionSep 7, 2023Failure to Fire; Expulsion; Failure to Fire; Expulsion
ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC VIDEO-ASSISTED THORACIC SURGERY (VATS) UPPER RIGHT LOBE RESECTION, DURING PULMONARY PARENCHYMA PULMONARY RESECTION, A PRE-FIRE OCCURRED PRIOR TO THE STAPLES BEING FIRED. THE DEVICE COULD NOT ADVANCE ANY FURTHER. WHEN ANOTHER FIRING WAS ATTEMPTED, AS THE TISSUE WAS HARD, SO THE FIRING DID NOT ADVANCE PROPERLY. ANOTHER BLACK RELOAD WAS USED WITH THE SAME HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17703496 ↗MalfunctionSep 7, 2023Failure to Fire; Expulsion; Failure to Fire; Expulsion
ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC VIDEO-ASSISTED THORACIC SURGERY (VATS) UPPER RIGHT LOBE RESECTION, DURING PULMONARY PARENCHYMA PULMONARY RESECTION, A PRE-FIRE OCCURRED PRIOR TO THE STAPLES BEING FIRED. THE DEVICE COULD NOT ADVANCE ANY FURTHER. WHEN ANOTHER FIRING WAS ATTEMPTED, AS THE TISSUE WAS HARD, SO THE FIRING DID NOT ADVANCE PROPERLY. ANOTHER BLACK RELOAD WAS USED WITH THE SAME HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17701949 ↗MalfunctionAug 23, 2023Misfire; Misfire
ACCORDING TO THE REPORTER, IN A LAPAROTOMY ESOPHAGEAL RESECTION, DURING GASTRIC TUBE FORMATION ON ESOPHAGEAL RESECTION, THE RELOAD WAS LOADED ON THE POWERED STAPLE AND TISSUE APPROACH WAS COMPLETED. THE FIRING STARTED IN SLOW MODE. WHEN THE STAPLER ADVANCED ABOUT HALFWAY, THE KNIFE RETURNED FROM THERE BY ITSELF. THE SURGEON ONLY PRESSED THE DOWN BUTTON FROM THE CENTRAL CONTROL BUTTONS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SUBSEQUENT RELOADS HAD NO ISSUES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17605229 ↗MalfunctionAug 21, 2023Break; Misfire; Difficult to Open or Close; Break; Misfire; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CUTTING RECTUM, THERE WAS INCOMPLETE GRASPING OF A NEW CLIP AND STAPLE; CLAMP DID NOT CLOSE PROPERLY, SO IT WAS BROKEN AND STAPLING IN HALF (INCOMPLETE STAPLING). THERE WERE TWO RELOADS AND ONE HANDLE INVOLVED. A THIRD RELOAD AND A NEW HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17587424 ↗MalfunctionAug 11, 2023Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY ESOPHAGEAL RECONSTRUCTION, THE FIRING COULD NOT BE DONE, BUT THE GREEN BUTTON COULD BE PRESSED AND HANDLE COULD BE SQUEEZED. THE RELOAD WAS REPLACED, WHILE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17512835 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K160176. One submission often covers many models, so check the product and lot details in each record.
- Z-1228-2023 · Jan 25, 2023 · Open, ClassifiedTri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- Z-1832-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
- Z-1833-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Z-1834-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
- Z-1829-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
- Z-1835-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
- Z-1825-2019 · May 17, 2019 · Open, ClassifiedEGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- Z-1827-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- Z-1830-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- Z-1831-2019 · May 17, 2019 · Open, ClassifiedEGIA45 CT AR MD THK REL, EGIA45CTAMT
- Z-1826-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- Z-1836-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
- Z-1828-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
- Z-1237-2018 · Dec 13, 2017 · TerminatedSignia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Sta
Other STAPLE, IMPLANTABLE devices
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- Signia SIGPHANDLECovidien LP · STAPLE, IMPLANTABLE1 recall3 deaths5,356 reports
- ECHELON FLEX PSEE60AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- ENDOPATH ATS45Ethicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE2 deaths2,046 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page