LAP-BAND System Access Port I Kit B-2101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10811955020084), received between Feb 23, 2017 and Jun 26, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2018Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH LAP-BAND SYSTEM COMPLAINED OF NO RESTRICTION. THE PHYSICIAN PERFORMED FLUOROSCOPY WITH CONTRAST WHICH SHOWED A LEAK AT THE PORT. THE PORT WAS REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 7638123 ↗
• MalfunctionFeb 23, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT'S LAP-BAND SYSTEM WAS REPORTED TO HAVE A "PORT REVISION DUE TO TUBING LEAK." PER OP REPORT, "VERIFIED THAT THE BREAK WAS AN EXCESSIVE ANGULATION OF THE TUBING THAT WAS KINKED, THERE WAS SOME SCAR TISSUE AT THE ENTRANCE OF THE TUBING THAT WAS PROBABLY CREATING A KINK AROUND THAT TUBING AREA." THE PORT WAS REMOVED AND REPLACED.

  Patient problems: Adhesion(s)

  MAUDE report 6355269 ↗