EluPro™ 66BE02-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00802526630002), received between Aug 9, 2026 and Sep 25, 2026 — classified as 4 injuries.

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.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this bioenvelope was part of a system revision due to infection. There was no additional adverse patient effects reported. The bioenvelope was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50897251 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this bioenvelope was part of a system revision due to infection. There were no additional adverse patient effects reported. The bioenvelope was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50807989 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50793372 ↗
• InjuryAug 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this bio-envelope was part of the system revision due to bacterial infection and sepsis. Reportedly, the implant pocket had oozing bloody purulent discharge. The bacterial culture was negative but there was no confirmation of the possible reaction to the bio-envelope. No adverse patient effects were reported. The bio-envelope was explanted.

  Patient problems: Bacterial Infection; Hypersensitivity/Allergic reaction; Purulent Discharge; Sepsis

  MAUDE report 50188147 ↗