LAP-BAND System Access Port II Kit B-2103Recalls & reported problems
Apollo Endosurgery, Inc. · ACCESS PORT II KIT · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10811955020091), received between Jan 10, 2017 and Jan 10, 2017 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Dysphagia/ Odynophagia1
- Regurgitation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTED AS: THE PATIENT'S LAP-BAND SYSTEM WAS REPORTED TO HAVE A "SEVERAL YEARS OF GERD AND DYSPHAGIA." THE PATIENT'S PORT WAS EXPLANTED.
Patient problems: Dysphagia/ Odynophagia; Regurgitation
MAUDE report 6237351 ↗
Other Implant, Intragastric For Morbid Obesity devices
- ORBERA Intragastric Balloon System B-4800Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity6 deaths327 reports
- ReShape™ Integrated Dual Balloon System RSM101Reshape Medical, Inc. · Implant, Intragastric For Morbid Obesity3 deaths98 reports
- LAP-BAND AP Adjustable Gastric Banding System B-2240Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity82 reports
- OBALON Touch™ 4300-0003Medtimo, Inc · Implant, Intragastric For Morbid Obesity1 recall0 reports
- LAP-BAND AP Adjustable Gastric Banding System B-2245Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity27 reports
- The LAP-BAND Adjustable Gastric Banding System B-2220Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity25 reports
- OBALON® Balloon Kit HPMC 7600-0001Medtimo, Inc · Implant, Intragastric For Morbid Obesity20 reports
- LAP-BAND AP Adjustable Gastric Banding System B-2260Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity18 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page