OCEAN 2020-000Recalls & reported problems
Atrium Medical Corporation · OCEAN DRAIN, DUAL, IN-LINE, STOP · Class 2
All models of OCEAN (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Atrium Medical Ocean dual in-line stop drain is a vacuum bottle used to collect fluid from the body after surgery. The 32 reports mostly describe the tubing arriving kinked, bent or twisted, sometimes deformed from compression, and a few mention the drain arriving already damaged. No deaths were reported and one injury was reported. There are no recalls naming this device, and no reports were filed in either the past or prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00650862102017), received between Jan 31, 2020 and Jul 16, 2020 — classified as 1 injury, 31 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (14 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Deformation Due to Compressive Stress14
- Material Deformation11
- Material Twisted/Bent7
- Device Damaged Prior to Use3
Patient problems
- No Consequences Or Impact To Patient32
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2020Device Damaged Prior to Use; Material Deformation
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10284288 ↗MalfunctionJul 16, 2020Material Deformation
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10284128 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10284123 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10284039 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
MalfunctionJul 16, 2020Material Deformation
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283662 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283661 ↗MalfunctionJul 16, 2020Material Deformation
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283657 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283648 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
MalfunctionJul 16, 2020Material Twisted/Bent
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283627 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283544 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283540 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283328 ↗MalfunctionJul 16, 2020Material Twisted/Bent
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283215 ↗MalfunctionJul 16, 2020Material Deformation
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283211 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10282582 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10282576 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10282574 ↗MalfunctionJul 16, 2020Device Damaged Prior to Use; Material Deformation
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10282573 ↗MalfunctionJul 16, 2020Material Twisted/Bent
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 10282457 ↗MalfunctionJul 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10282456 ↗MalfunctionJul 15, 2020Material Twisted/Bent
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10281003 ↗MalfunctionJul 15, 2020Material Deformation
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10281002 ↗MalfunctionJul 15, 2020Material Twisted/Bent
IT WAS REPORTED THAT ON REMOVAL OF THE DRAIN FROM THE PACKAGING THE PATIENT TUBING WAS NOTED TO BE KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10281001 ↗
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, ClassifiedAtrium 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, ClassifiedAtrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
- Z-1607-2022 · May 25, 2022 · Open, ClassifiedGETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
- Z-0307-2022 · Oct 22, 2021 · Open, ClassifiedThe 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-1205-2017 · Dec 23, 2016 · TerminatedMaquet 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 · TerminatedMaquet 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-1210-2017 · Dec 23, 2016 · TerminatedMaquet 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-1206-2017 · Dec 23, 2016 · TerminatedMaquet 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-1936-2015 · May 7, 2015 · TerminatedOcean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
- Z-1938-2015 · May 7, 2015 · TerminatedEXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
- Z-1935-2015 · May 7, 2015 · TerminatedOcean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
- Z-1937-2015 · May 7, 2015 · TerminatedOasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
- Z-1959-2014 · Apr 28, 2014 · TerminatedAtrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
- Z-0738-2014 · Nov 19, 2013 · TerminatedAtrium 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
- Z-0740-2014 · Nov 19, 2013 · TerminatedAtrium 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
…and 7 more.
Other BOTTLE, COLLECTION, VACUUM devices
- OASIS 3600-100Atrium Medical Corporation · Bottle, Collection, Vacuum3 recalls1 death175 reports
- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- EXPRESS 16400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall110 reports
- EXPRESS 4000-100NAtrium Medical Corporation · Bottle, Collection, Vacuum2 recalls30 reports
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OASIS 3612-100Atrium Medical Corporation · Bottle, Collection, Vacuum1 recall18 reports
- Medline DYNDSCL1500Medline Industries, Inc. · BOTTLE, COLLECTION, VACUUM1 recall13 reports
- PNEUMOSTAT 16100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 deaths12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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