OCEAN 2012-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00650862101027), received between Apr 17, 2020 and Aug 25, 2020 — classified as 3 malfunctions.

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

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

22 other recalls cover devices cleared under the same FDA submission (K043582); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2020Adverse Event Without Identified Device or Use Problem

  N/A

  Patient problems: No Code Available

  MAUDE report 10452306 ↗
• MalfunctionMay 7, 2020Suction Problem

  CHEST TUBE FLUID IN SUCTION CHAMBER WAS CLEAR AND NOT DYED BLUE. NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10035029 ↗
• MalfunctionApr 17, 2020Material Integrity Problem

  RECEIVED REPORT OF EVENT OF THE DRAIN GOING DRY. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9971461 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043582. One submission often covers many models, so check the product and lot details in each record.

• Z-0486-2024 · Sep 5, 2023 · Open, Classified
  Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
• Z-0235-2023 · Oct 18, 2022 · Open, Classified
  Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
• Z-1607-2022 · May 25, 2022 · Open, Classified
  GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
• Z-0307-2022 · Oct 22, 2021 · Open, Classified
  The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber us
• Z-1206-2017 · Dec 23, 2016 · Terminated
  Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-estab
• Z-1210-2017 · Dec 23, 2016 · Terminated
  Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lun
• Z-1205-2017 · Dec 23, 2016 · Terminated
  Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establ
• Z-1209-2017 · Dec 23, 2016 · Terminated
  Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish
• Z-1938-2015 · May 7, 2015 · Terminated
  EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
• Z-1937-2015 · May 7, 2015 · Terminated
  Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
• Z-1936-2015 · May 7, 2015 · Terminated
  Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
• Z-1935-2015 · May 7, 2015 · Terminated
  Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
• Z-1959-2014 · Apr 28, 2014 · Terminated
  Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
• Z-0739-2014 · Nov 19, 2013 · Terminated
  Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the
• Z-0735-2014 · Nov 19, 2013 · Terminated
  Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from th

…and 7 more.