Reliamax GIA6025RLRecalls & reported problems

Covidien LP · Gastrointestinal Anastomosis Reload · Class 2 · Implant

All models of Reliamax (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521168609), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Fire” (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

Failure to Fire1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 15, 2017Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A HEPATECTOMY PROCEDURE, AFTER THE SURGEON CONNECTED THE RELOAD AND TRIED TO FIRE THE DEVICE, THE FIRING KNOB WAS STIFF AND THE KNIFE WOULD NOT ADVANCE AND THE DEVICE COULD NOT BE FIRED. THE SURGEON REPLACED IT WITH A NEW CARTRIDGE AND THE FIRING WAS COMPLETED WITH NO ISSUES. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7034115 ↗

Device details

UDI-DI	`20884521168609`
Brand	Reliamax
Model	GIA6025RL
Company	Covidien LP
Product code	GDW · STAPLE, IMPLANTABLE
Class	Class 2
FDA submission	K122781
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	Not in Commercial Distribution
Record updated	Dec 30, 2025

Device type (GMDN): Surgical staple loading unit, non-cutting

A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

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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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