FDA recall Z-0201-2020

Product

ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A

Reason for recall

The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.

Distribution

Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.

Key facts

Status

Terminated

Initiation date

2019-10-03

Report date

2019-11-06

Termination date

2021-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Blue Ash, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0201-2020