The LAP-BAND Adjustable Gastric Banding System B-2210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10811955020145), received between May 3, 2013 and Nov 21, 2017 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE BEEN "EVALUATED FOR A LAP BAND TUBING LEAK." [PATIENT] "FELT THERE WAS NO RESTRICTION AND THERE WAS MINIMAL FLUID IN [THEIR] SYSTEM. WHEN SALINE WAS INJECTED IT DID NOT RETURN FULL VOLUME. X-RAY SHOWED PROXIMAL TUBING LEAK, WHICH REQUIRED LAPAROSCOPY TO REPAIR. LEAK WAS TOO CLOSE TO BAND TO REPAIR AT LAPAROSCOPY." DEVICE WAS REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 7049844 ↗
• MalfunctionApr 24, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "DEFECTIVE BAND, LOCATION OF WHERE THE PORT AND THE TUBING MEETS HAS A HOLE IN IT". PHYSICIAN CONFIRMED, DEVICE REMAINS IMPLANTED AT THIS TIME, BUT WILL BE REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 6516383 ↗
• MalfunctionFeb 10, 2017Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO HAVE "OVER THE PAST SIX OR SO MONTHS [PATIENT] HAD NOTICED NO RESTRICTION, AND HAD GAINED LOTS OF WEIGHT. [PATIENT] WAS FOUND TO NOT HAVE ANY VOLUME IN [PATIENT'S] LAP BAND IN THE CLINIC. A DIAGNOSTIC STUDY WAS DONE REVEALING A LARGE LEAK IN THE TUBING. IT WAS DIFFICULT TO TELL WERE THE LEAK WAS LOCATED WHETHER IT WAS DISTAL NEAR THE PORT OR PROXIMAL NEAR THE LAP BAND. A DIAGNOSTIC LAPAROSCOPY WAS DONE TO GET AT THE SECTION, WITH HOPES OF REPAIRING THE TUBING BY EXTERIORIZING THE LEAK AND BRING IN INTO THE SURFACE AND SLICING A NEW PIECE OF TUBING, HOWEVER THERE WAS A POSSIBILITY THAT THIS WILL BE TOO CLOSE TO THE LAP BAND ITSELF. THAT REQUIRED ULTIMATELY REPLACING THE ENTIRE SYSTEM." THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Weight Changes

  MAUDE report 6323455 ↗
• MalfunctionOct 27, 2015Leak/Splash

  REPORTED AS: PATIENT COMPLAINED OF NO RESTRICTION OF THEIR LAP-BAND SYSTEM DURING A VISIT. THE PHYSICIAN PERFORMED AN ULTRASOUND OF THE ABDOMEN WITH FLUOROSCOPY, AND A CRACK IN THE TUBING WAS NOTED. THE LAP-BAND PORT WAS REMOVED AND REPLACED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5181508 ↗
• MalfunctionApr 13, 2015Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED PT "COMPLAINED OF SUDDEN LACK OF RESTRICTION" AND DURING AN ADJUSTMENT THE PHYSICIAN WAS UNABLE TO WITHDRAW AS MUCH SALINE AS INDICATED SHOULD HAVE BEEN IN THE BAND. THE FLUOROSCOPY WAS "INCONCLUSIVE FOR LEAK" AND THE "PT WANTED TO HAVE THE PORT REPLACED ANYWAY". THE PORT WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 4693029 ↗
• MalfunctionMay 3, 2013Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND "BROKEN TUBING" AND "LEAK/BREAK IN TUBING." THE EVENT WAS FIRST NOTED WHEN THE PATIENT REPORTED "SUDDEN LOSS OF SATIETY." THE "BROKEN TUBING PIECES" WERE EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 3101810 ↗