Recall Z-2743-2018— Apollo Endosurgery Inc

Class II FDA medical device recall by Apollo Endosurgery Inc, initiated 2017-11-22, terminated 2020-10-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food consumption. The band can be inflated or deflated with saline, through the access port, depending on patient needs and progress. The Lap-Band access port is a low-profile cylindrical port attached to kink-resistant tubing . The port is implanted subcutaneously or in the rectus muscle and can be penetrated in its silicone septum by a non-coring needle to inject or remove saline into or from the band. The kink-resistant tubing connects the access port to the band.. Reason: Component of the Lap-Band system was missing from the package.

Recalling firm

Apollo Endosurgery Inc

Classification

Class II

Status

Terminated

Initiated

2017-11-22

Terminated

2020-10-06

Firm location

West Lake Hills, TX, United States

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