Medtronic (NYSE:MDT) has issued another select recall of its Endo GIA surgical staplers, this time for single use loading units, Tri-Staple 2.0 intelligent reloads and cartridges over potential missing components, the company said in a recently posted urgent field safety notice.
The Fridley, Minn.-based company said it is voluntarily recalling the devices due to the potential that they could be missing one of two pin components intended to maintain alignment of the device jaws.
Using a product with a missing pin may result in incomplete staple formation which could lead to bleeding, anastomotic leak, peritonitis or pneumothorax which could result in the potential for infection or sepsis, Medtronic said.
The company said that it identified the issue during in-process quality testing at the manufacturing facility, and that it has already implemented manufacturing process improvements to address the issue. No confirmed complaints have been received related to the issue, the company added.
The recall affects select lots of devices with item codes EGIA30AMT, EGIA45AVM, EGIA45CTAMT, EGIA60AXT, EGIA60CTAMT, SIG30AMT, SIG45AXT, SIG45CTAMT, SIG60AXT, SIG60CTAMT, EGIA45AMT and EGIA60AMT that were distributed between April 2014 and April 2019.
Medtronic requested that customers with the affected products discontinue use, quarantine and return the items to the company, according to the urgent field safety notice.
Early last month, Medtronic issued a select recall for specific Covidien Endo GIA staplers over possible missing components, according to a safety field notice from the company.