Hollister 9782Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075097821), received between Apr 9, 2024 and Apr 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 11, 2021Terminated

   The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might contribute to the potential risk of the tube/drain/catheter migration or loss.

   Z-1311-2021 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE CLAMP PORTION SECURING A 16 FRENCH TUBE SEPARATED FROM THE BARRIER PORTION OF A HOLLISTER VERTICAL DRAIN TUBE ATTACHMENT DEVICE. IT WAS REPORTED THAT THE SEPARATION OCCURRED SOMETIME BETWEEN HOME HEALTH CARE NURSE VISITS WHICH OCCURRED EVERY 3 DAYS. IT WAS FURTHER REPORTED THAT THERE WAS NO INJURY OR HARM TO THE END USER ASSOCIATED WITH THIS SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069779 ↗