Apollo Endosurgery, Inc.
FDA adverse event reports naming Apollo Endosurgery, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: APOLLO ENDOSURGERY, INC..
- Total reports
- 1,565
- Deaths
- 19
- Injuries
- 612
- Malfunctions
- 934
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2014-09-30TerminatedSoftware Manufacturing/Software Deployment
LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
Product was distributed past its expiration date.
- TerminatedUnder Investigation by firm
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.
Component of the Lap-Band system was missing from the package
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