NA RLZB32Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705036004001), received between Mar 6, 2018 and Aug 5, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 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.

• MalfunctionAug 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SURGEON STATED THAT THE BAND HAS A LEAK. THE BAND IS STILL IMPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720567 ↗
• InjuryMar 26, 2025Disconnection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Disconnection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  SEE ATTACHED MEDWATCH FORM #MW5165900.

  Patient problems: Discomfort; Failure of Implant; Hypoglycemia; Unspecified Tissue Injury

  MAUDE report 21698889 ↗
• InjuryApr 25, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE BAND WAS EXPLANTED AT THE PATIENT¿S REQUEST DUE TO GERD AND DYSPHAGIA. THE PATIENT HAD ALSO BEEN SUFFERING FROM PROBLEMS FROM ANOTHER PROCEDURE UNRELATED TO THE BAND. THE SURGEON WAS NOT THE IMPLANT SURGEON AND DID NOT HAVE THE DATE OF IMPLANT OTHER THAN TO SAY, ¿SIX TO SEVEN YEARS AGO.¿ THE STRAIN RELIEF DOES NOT APPEAR IN THE PHOTOS PROVIDED. THE SURGEON WAS ASKED IF THERE HAD BEEN A PORT REPLACEMENT AFTER THE BAND WAS IMPLANTED BUT HE DID NOT RESPOND AS HE WAS NOT THE IMPLANT SURGEON AND DIDN¿T SEEM TO HAVE HISTORICAL INFORMATION AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 7458848 ↗
• MalfunctionMar 6, 2018Device Slipped

  IT WAS REPORTED THAT THE REALIZE BAND WAS IMPLANTED IN (B)(6) 2010. TWO YEARS LATER, THE PATIENT WASN'T ABLE TO PASS ANY FOOD, WHICH RESULTING IN VOMITING ALL FOOD EATEN. THE PATIENT WENT TO HER DOCTOR AND THE DOCTOR NOTIFIED HER THERE WERE ISSUES WITH THE REALIZE BAND AND RECOMMENDED THE PRODUCT BE REMOVED. THE PATIENT WAS INFORMED THAT THE BAND HAD SLIPPED. THE PATIENT HAD THE PRODUCT REMOVED IN (B)(6) 2015.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317996 ↗