OCEAN 2002-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00650862100211), received between Jun 22, 2017 and May 5, 2021 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Backflow” (7 reports).

2 FDA recall records name this device's identifier, 2 still open.

21 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 ↗

2. Oct 22, 2021Open, Classified

   Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

   Z-0307-2022 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2021Missing Information; Missing Information

  N/A

  Patient problems: Pneumothorax; Stroke/CVA

  MAUDE report 11781085 ↗
• MalfunctionSep 24, 2019Component Missing

  N/A

  Patient problems: No Patient Involvement

  MAUDE report 9108975 ↗
• InjuryNov 2, 2018Backflow

  REPORT RECEIVED STATED THAT AFTER WALL SUCTION WAS CONNECTED TO THE DRAIN THE FLUID FROM THE CHAMBER WAS DRAWN INTO THE SUCTION TUBE.

  Patient problems: No Information

  MAUDE report 8033717 ↗
• InjuryNov 2, 2018Backflow

  N/A.

  Patient problems: No Information

  MAUDE report 8033708 ↗
• InjuryNov 2, 2018Backflow

  REPORT RECEIVED STATED THAT AFTER WALL SUCTION WAS CONNECTED TO THE DRAIN THE FLUID FROM THE CHAMBER WAS DRAWN INTO THE SUCTION TUBE.

  Patient problems: No Information

  MAUDE report 8033707 ↗
• InjuryNov 2, 2018Backflow

  N/A.

  Patient problems: No Information

  MAUDE report 8033706 ↗
• InjuryNov 2, 2018Backflow

  REPORT RECEIVED STATED THAT AFTER WALL SUCTION WAS CONNECTED TO THE DRAIN THE FLUID FROM THE CHAMBER WAS DRAWN INTO THE SUCTION TUBE.

  Patient problems: No Information

  MAUDE report 8033705 ↗
• InjuryNov 2, 2018Improper Flow or Infusion

  N/A.

  Patient problems: No Information

  MAUDE report 8033702 ↗
• InjuryNov 2, 2018Suction Problem

  N/A.

  Patient problems: No Information

  MAUDE report 8033701 ↗
• InjuryNov 2, 2018Backflow

  N/A.

  Patient problems: No Information

  MAUDE report 8033700 ↗
• InjuryNov 2, 2018Suction Problem

  N/A.

  Patient problems: No Information

  MAUDE report 8033698 ↗
• InjuryNov 2, 2018Backflow

  REPORT RECEIVED STATED THAT AFTER WALL SUCTION WAS CONNECTED TO THE DRAIN THE FLUID FROM THE CHAMBER WAS DRAWN INTO THE SUCTION TUBE.

  Patient problems: No Information

  MAUDE report 8033696 ↗
• MalfunctionOct 17, 2017Device Packaging Compromised

  CUSTOMER REPORTED THEY NOTICED THAT THE INNER PACKAGE OF THE CHEST DRAIN WAS DAMAGED, SMALL SLITS WERE FOUND IN THE INNER PACKAGE. STERILITY COULD NOT BE ENSURED.

  Patient problems: No Patient Involvement

  MAUDE report 6955622 ↗
• InjuryJun 22, 2017Insufficient Device Problem Information

  REPORT RECEIVED STATED A DOCTOR WAS HAVING AN ISSUE WITH A PATIENT REGARDING A COLLAPSED LUNG WHEN USING AN OCEAN DRAIN.

  Patient problems: Pneumothorax

  MAUDE report 6660061 ↗
• InjuryJun 22, 2017Appropriate Device Problem Term/Code Not Available

  REPORT RECEIVED STATED A DOCTOR WAS HAVING AN ISSUE WITH A PATIENT REGARDING A COLLAPSED LUNG WHEN USING AN OCEAN DRAIN.

  Patient problems: No Code Available

  MAUDE report 6660057 ↗
• InjuryJun 22, 2017Device Operates Differently Than Expected

  REPORT RECEIVED STATED A DOCTOR WAS HAVING AN ISSUE WITH A PATIENT REGARDING A COLLAPSED LUNG WHEN USING AN OCEAN DRAIN.

  Patient problems: Pneumothorax

  MAUDE report 6660045 ↗
• InjuryJun 22, 2017Device Operates Differently Than Expected

  REPORT RECEIVED STATED A DOCTOR WAS HAVING AN ISSUE WITH A PATIENT REGARDING A COLLAPSED LUNG WHEN USING AN OCEAN DRAIN.

  Patient problems: Pneumothorax

  MAUDE report 6660040 ↗
• InjuryJun 22, 2017Adverse Event Without Identified Device or Use Problem

  REPORT RECEIVED STATED A DOCTOR WAS HAVING AN ISSUE WITH A PATIENT REGARDING A COLLAPSED LUNG WHEN USING AN OCEAN DRAIN.

  Patient problems: Pneumothorax

  MAUDE report 6660036 ↗

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-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-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-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-1937-2015 · May 7, 2015 · Terminated
  Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
• Z-1938-2015 · May 7, 2015 · Terminated
  EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
• 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-0740-2014 · Nov 19, 2013 · Terminated
  Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the
• Z-0736-2014 · Nov 19, 2013 · Terminated
  Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or f
• Z-0738-2014 · Nov 19, 2013 · Terminated
  Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air a

…and 6 more.