LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ B-2365Recalls & reported problems
Apollo Endosurgery, Inc. · LAP-BAND AP Large with RAPIDPORT EZ · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10811955020275), received between Feb 18, 2015 and Nov 16, 2018 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Slipped” (2 reports).
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
- Device Slipped2
- Fluid/Blood Leak1
Patient problems
- Dysphagia/ Odynophagia2
- Failure of Implant1
- Hernia1
- Regurgitation1
- Vomiting1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2018Fluid/Blood Leak; Fluid/Blood Leak
REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE A "LEAK AT THE SEAM.": "(EX. LOCATION OF THE "SEAM") INSIDE SEAM WEAR WHITE SHELL OF BAND AND THE CLEAR BLADDER MEET UP WAS WHERE THE LEAK WAS LOCATED". THE DEVICE WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 8077968 ↗InjuryMar 1, 2018Device Slipped; Device Slipped
REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "STARTED TO VOMIT AND COULDN'T EVEN KEEP DOWN WATER. MULTIPLE TESTS WERE DONE AND IT WAS IDENTIFIED THAT [PATIENT'S] BAND SLIPPED." THE DEVICE WAS REMOVED. ADDITIONAL INFORMATION PROVIDED BY THE OPERATIVE NOTE: THE PATIENT HAS DEVELOPED SEVERE DYSPHAGIA AND VOMITING. INTRAOPERATIVE FINDINGS NOTED "LAP-BAND IN APPROPRIATE POSITION, NO EVIDENCE OF A SIGNIFICANT SLIP." PREOPERATIVE EGD DEMONSTRATED A HIATAL HERNIA.
Patient problems: Dysphagia/ Odynophagia; Hernia; Vomiting
MAUDE report 7306123 ↗InjuryFeb 18, 2015Device Slipped
HEALTHCARE PROFESSIONAL REPORTED "GASTRIC BAND PROLAPSE", THE PATIENT BEGAN TO DEVELOP DYSPHAGIA AND REFLUX AND WAS DIAGNOSED WITH ESOPHAGEAL DILATATION. THE LAP-BAND SYSTEM WAS REMOVED, HOWEVER IT IS NOT KNOWN IF IT WAS REPLACED.
Patient problems: Dysphagia/ Odynophagia; Regurgitation
MAUDE report 4531308 ↗
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.
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