Recall Z-0070-2019— COVIDIEN LLC

Name: FDA recall Z-0070-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-17

Class II · Terminated

Class II FDA medical device recall by COVIDIEN LLC, initiated 2018-08-17, terminated 2020-04-10. It names one FDA 510(k) clearance: K172361. Product: EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.. Reason: 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..

Recalling firm: COVIDIEN LLC
Classification: Class II
Status: Terminated
Initiated: 2018-08-17
Terminated: 2020-04-10
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K172361 — EEA Circular Stapler with Tri-Staple TechnologyCovidien·cleared 2018-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.