Covidien recalls EEA Circular Staplers with Tri-Staple Technology due to potential incorrect tissue gap causing incomplete staples or tissue trauma. No serious injuries reported.
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
Covidien is recalling EEA Circular Staplers with Tri-Staple Technology because they might have an incorrect tissue gap. This could lead to incomplete staple formation or difficulty removing the device, potentially causing bleeding or tissue damage. No serious injuries have been reported from this issue.
The stapler may have an incorrect tissue gap, which can cause the staples to not form properly or become stuck in tissue. This might lead to bleeding, tissue damage, or complications during surgery.
Surgical professionals who use these staplers for circular anastomosis procedures are most at risk. Patients undergoing surgery with these devices may experience bleeding or tissue trauma if the staple gap is incorrect.
Check for the model numbers TRIEEA28MT, TRIEEA28XT, TRIEEA31MT, or TRIEEA31XT on the stapler. These models were sold with the Tri-Staple Technology.
Look for the model numbers TRIEEA28MT, TRIEEA28XT, TRIEEA31MT, or TRIEEA31XT on the stapler.
No serious injuries have been reported related to this issue.
The recall does not specify a remedy, so check the model number and contact Covidien for further instructions.
Look for the model numbers TRIEEA28MT, TRIEEA28XT, TRIEEA31MT, or TRIEEA31XT on the stapler.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0070-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0070-2019 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
