The Fridley, Minn.-based company warned that the Endo GIA articulating loading units could possibly be missing a sled component designed for staple deployment, making it unable to deploy staples.
“Use of a product with this issue may result in a failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents,” the company wrote in a field safety notice.
Medtronic said it has received four reports of injuries related to the issue.
A total of ten item codes and 95 affected lots were identified for Endo GIA units globally, with 44 item codes and 179 affected lots identified specifically for customers in the European Union, according to the safety field notice.
Medtronic instructed users with affected units to immediately discontinue use of the devices and to quarantine and return unused products affected by the recall. The company added that it has contacted the appropriate regulatory bodies about the issue.
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