Reliamax GIA60RSRecalls & reported problems
Covidien LP · Reusable Gastrointestinal Anastomosis Stapler · Class 2
All models of Reliamax (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521174894), received between Oct 11, 2017 and Jul 23, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Human-Device Interface Problem1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, AT THE FIRST FIRING DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, WHEN THE RELOAD WAS ATTACHED, THE KNOB BROKE AND CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8815591 ↗MalfunctionMar 18, 2019Human-Device Interface Problem; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A SIGMOIDECTOMY PROCEDURE, AT THE FIRST FIRING, WHEN THE DEVICE WAS ABOUT TO BE FIRED, THE SAFETY LOCK GOT FUNCTIONAL AND THE DEVICE WAS UNABLE TO BE FIRED. IT WAS UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8430527 ↗MalfunctionOct 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE DEVICE HAD A COMPRESSION PROBLEM, THE STAPLE LINE WAS BLEEDING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6940679 ↗
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 18, 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