OCEAN 2050-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00650862103014), received between Nov 21, 2016 and Mar 28, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. Sep 18, 2023Open, Classified

   Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

   Z-0316-2024 · Root cause: Error in labeling · FDA record ↗

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.

• MalfunctionMar 28, 2022No Apparent Adverse Event; No Apparent Adverse Event

  REPORT RECEIVED STATED THAT THE TETHERED STOPPER (VENT PLUG) ON TOP OF THE DRAIN WAS MISSING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934437 ↗
• InjuryNov 21, 2016Device Operates Differently Than Expected

  REPORT RECEIVED STATED THAT A COVIDIEN 24FR CHEST TUBE COULD NOT BE ATTACHED TO THE CONNECTOR OF AN OCEAN DRAIN. ANOTHER DRAIN WAS OPENED AND THEY WERE ABLE TO ATTACH THE CHEST TUBE.

  Patient problems: No Information

  MAUDE report 6119506 ↗