Reliamax GIA80RSRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521174887), received between Jul 23, 2018 and May 22, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (2 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, 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
- Failure to Fire2
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2019Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A RIGHT HEMICOLECTOMY, DURING TRANSECTION OF COLON, THE DEVICE DID NOT FIRE. THEY OPENED ANOTHER R ELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8632841 ↗MalfunctionJul 23, 2018Failure to Fire
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC COLECTOMY, THEY CONNECTED THE DEVICE TO THE RELOAD, THEN THE SURGEON TRIED TO FIRE THE DEVICE, HOWEVER COULD NOT. REPLACED BY NEW RELOAD, AND CONNECTED TO THE SAME INSTRUMENT, HOWEVER THE SAME EVENT OCCURRED. REPLACED BY ANOTHER NEW RELOAD WITH A DIFFERENT LOT NO. AND CONNECTED TO THE SAME INSTRUMENT, AND THE FIRING WAS SUCCESSFUL. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7710335 ↗
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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.
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