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EEA
Covidien LP · Model TRIEEA21XT · UDI-DI 10884521592995
1
510(k) clearances
170,750
Adverse events (1,103 deaths)
225
Recalls
156
Facilities
Description
Circular Stapler with Tri-Staple Technology
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-25 | Covidien, LP | 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. |
| 2025-09-25 | Covidien, LP | 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. |
| 2025-09-11 | Ethicon Endo-Surgery Inc | The devices were shipped unsterilized. |
| 2025-04-22 | Ethicon Endo-Surgery Inc | Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily ac |
| 2024-08-12 | Smith & Nephew Inc. | Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
| 2024-08-12 | Smith & Nephew Inc. | Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
| 2024-04-15 | Covidien, LP | Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery |
| 2024-02-14 | Covidien, LP | 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 |
| 2024-02-14 | Covidien, LP | 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 |
| 2023-12-11 | Ethicon Endo-Surgery Inc | There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could req |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.