LAP-BAND® AP System Large with RapidPort® EZ C-2365Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850007764654), received between Jul 26, 2022 and Nov 19, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT # MW5162807 WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. THE REPORT RECEIVED IS A DUPLICATE OF REPORT # MW5159479. THE PATIENT PRESENTED WITH MILD EPIGASTRIC PAIN AND REFLUX AND UPPER ENDOSCOPY WAS PERFORMED, WHICH REVEALED ERODED LAP-BAND AND LAP BAND REMOVAL WAS RECOMMENDED. LAP BAND WAS FOUND PENETRATING IN THE CARDIA ON THE GREATER CURVE SIDE. NO INFLAMMATION WAS REALLY NOTED. THE SURGEON CUT THE LAP BAND INTO PIECES TO REMOVE AND ONE WAS LEFT BEHIND, WHICH THEY HAD TO GO BACK TO RETRIEVE.

  Patient problems: Erosion; Heartburn/Indigestion; Pain; Unspecified Infection

  MAUDE report 20729653 ↗
• InjuryNov 1, 2024Device Slipped; Device Slipped

  AP SMALL BAND WAS IMPLANTED IN 2008. AROUND (B)(6) 2024, THE PATIENT HAD THE BAND SLIP AND WAS VOMITING, COUGH AND GERD. IN (B)(6) 2024, THE PATIENT HAD THE BAND REVISION (REPLACED) WITH AN AP LARGE BAND WITH THE FLEX 2.0. DURING THE REVISION/RETROFIT, A HIATAL HERNIA WAS FOUND AND REPAIRED.

  Patient problems: Cough; Hernia; Vomiting

  MAUDE report 20589007 ↗
• InjuryNov 1, 2024Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS THE AP LARGE BAND WITH 2.0 FLEX IMPLANTED THE (B)(6) 2024. THE PATIENT WAS READMITTED 24 DAYS AFTER POST-OP WITH FOOD BLOCKAGE (ESOPHAGEAL FOOD IMPACTION). THE PATIENT CHANGED HIS DIET PREMATURELY. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AND HAD A PROLONGED ESOPHAGOGASTRODUODENOSCOPY (EGD) TO REMOVE THE FOOD BLOCKAGE (FOOD DISIMPACTION).

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 20589003 ↗
• MalfunctionJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGEON REPORTED A PORT TUBING DISLOCATION IN A PATIENT THAT HE IMPLANTED A NEW BAND SYSTEM INTO ONE WEEK AGO. PATIENT LAP BAND PLACED (B)(6) 2022 WITHOUT ISSUE, THEN 5 DAYS LATER HAD PELVIC PAIN AND A CT AT ER SHOWED DISCONNECTED TUBING HANGING IN PELVIS.

  Patient problems: Pain

  MAUDE report 15108974 ↗