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LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ B-2360Recalls & reported problems

Apollo Endosurgery, Inc. · LAP-BAND AP Standard with RAPIDPORT EZ · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10811955020268), received between Mar 10, 2016 and Aug 1, 2018 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (3 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

  • Adverse Event Without Identified Device or Use Problem3
  • Device Slipped3
  • Fluid/Blood Leak2
  • Inadequacy of Device Shape and/or Size1

Patient problems

  • Patient Problem/Medical Problem4
  • Abdominal Pain1
  • Dysphagia/ Odynophagia1
  • Dyspnea1
  • Hernia1
  • Internal Organ Perforation1
  • No Known Impact Or Consequence To Patient1
  • Pain1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 1, 2018Device Slipped; Device Slipped

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM REPORTED DEVICE SLIPPAGE ALL THE WAY DOWN TO THE STOMACH. PATIENT ALSO EXPERIENCED DIFFICULTY DRINKING WATER, GERD, HERNIA AND BERRETT'S ESOPHAGUS WITH LAP-BAND. PATIENT HAD AN EMERGENCY SURGERY TO REMOVE THE DEVICE.

    Patient problems: Dysphagia/ Odynophagia; Hernia; Regurgitation

    MAUDE report 7740108 ↗
  • InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REPORTED AS: THE PATIENT HAD THEIR ENTIRE LAP-BAND SYSTEM REMOVED DUE TO "FREQUENT VOMITING AND BAND INTOLERANCE".

    Patient problems: Patient Problem/Medical Problem; Vomiting

    MAUDE report 7003572 ↗
  • InjuryNov 1, 2017Device Slipped; Device Slipped

    REPORTED AS: A PATIENT IN THE (B)(6) CLINICAL STUDY HAD AN ADVERSE EVENT OF "SLIPPAGE, GASTRIC BAND". THE PATIENT WAS HOSPITALIZED AND BAND REOPERATION WAS PERFORMED FOR LAP-BAND SYSTEM ADJUSTMENT. DEVICE REMAINS IMPLANTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6993772 ↗
  • InjuryFeb 21, 2017Device Slipped; Device Slipped

    REPORTED AS: A PATIENT IN THE (B)(6) CLINICAL STUDY HAD REVISION SURGERY FOR BAND REPOSITION DUE TO "BAND SLIPPAGE." DEVICE REMAINS IMPLANTED.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 6348121 ↗
  • InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REPORTED AS: A PATIENT IN THE (B)(6) CLINICAL STUDY EXPERIENCED "ABDOMINAL PAIN." PATIENT WAS HOSPITALIZED AND THE LAP-BAND WAS REMOVED.

    Patient problems: Abdominal Pain

    MAUDE report 6306048 ↗
  • InjuryJan 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REPORTED AS: A PATIENT IN THE (B)(6) CLINICAL STUDY "PRESENTED TO THE EMERGENCY ROOM (ER) WITH SUDDEN SHARP LEFT UPPER QUADRANT PAIN AND SHORTNESS OF BREATH". PATIENT UNDERWENT EMERGENCY SURGERY FOR REMOVAL OF LAP-BAND DUE TO "PERFORATED STOMACH".

    Patient problems: Dyspnea; Internal Organ Perforation; Pain

    MAUDE report 6222072 ↗
  • MalfunctionJun 28, 2016Fluid/Blood Leak; Fluid/Blood Leak

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "HAD PROBLEMS WITH TUBING DISRUPTIONS ON AT LEAST THREE DIFFERENT OCCASIONS." THE PORT SYSTEM WAS REMOVED AND REPLACED.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 5755160 ↗
  • MalfunctionMar 10, 2016Fluid/Blood Leak; Inadequacy of Device Shape and/or Size; Fluid/Blood Leak; Inadequacy of Device Shape and/or Size

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE COME "IN DUE TO NO RESTRICTION. THE REPORTER WAS UNSURE IF ANY DIAGNOSTICS TESTS WERE DONE PRIOR TO SURGERY. SURGERY WAS DONE TO EVALUATE IF PATIENT NEEDED A REVISION. IT WAS DISCOVERED THAT THE LAP-BAND WAS LEAKING (A HOLE) EITHER BETWEEN THE BUCKLE AND THE RING OR THE BELT AND THE INNER SHELL. THE LAP-BAND SYSTEM WAS REPLACED.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 5493698 ↗

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Sources and updates

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