OCEAN 2002-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00650862100013), received between May 3, 2016 and Sep 15, 2022 — classified as 7 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (13 reports).

3 FDA recall records name this device's identifier, 3 still open.

20 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 18, 2022Open, Classified

   Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.

   Z-0235-2023 · Root cause: Storage · FDA record ↗

3. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1607-2022 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  N/A

  Patient problems: Insufficient Information

  MAUDE report 15430180 ↗
• MalfunctionAug 1, 2022Leak/Splash; Leak/Splash

  PT WITH 2 CHEST TUBES (OCEAN) TO -20 SUCTION S/P THORACOTOMY. PT DID NOT HAVE AIR LEAK PREVIOUSLY, BUT NOTED CONTINUOUS BUBBLING IN AIR LEAK CHAMBER. COLLECTION TUBING WAS CLAMPED AND AIR LEAK STILL SHOWING AS PRESENT. CONNECTIONS CHECKED AND TIGHTENED/NO VISIBLE HOLES IN TUBING. AIR LEAK REMAINED ISSUE SO DRAIN WAS SWAPPED OUT AND NO AIR LEAK PRESENT WITH NEW DRAIN.

  Patient problems: Insufficient Information

  MAUDE report 15139255 ↗
• MalfunctionApr 11, 2022Leak/Splash; Leak/Splash

  REPORT RECEIVED STATED THAT THE FACILITY FELT THERE WAS A POSSIBLE AIR LEAK IN THE OCEAN DRAIN EVEN AFTER CHECKING CONNECTIONS, BECAUSE THEY WERE UNAWARE IF BUBBLING WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075346 ↗
• MalfunctionSep 2, 2021Use of Device Problem; Connection Problem; Use of Device Problem

  PHYSICIAN CALLED COMPLAINING THAT THE OCEAN DRAIN WAS SET UP INCORRECTLY. THERE WAS NO WATER IN THE WATER SEAL AND THE WATER COLUMN FOR SUCTION CONTROL WAS NOT BUBBLING. THE ICU AND OPERATING ROOM STAFF HAD BEEN TRAINED THAT MORNING ON THE DRAIN. IN SPITE OF THE TRAINING THE DRAIN WAS STILL SET UP INCORRECTLY. THE SALES REP AND THE PHYSICIAN CORRECTED THE ISSUE WITH SUCTION AND WATER SEAL AND EVERYTHING WORKED PROPERLY. ADDITIONAL TRAINING WAS CONDUCTED FOR THE ICU STAFF. THE SURGEON WAS SATISFIED AND THE PATIENT SEEMED TO BE DOING WELL WITH NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418948 ↗
• MalfunctionMar 17, 2021Decrease in Suction; Decrease in Suction

  REPORT RECEIVED STATED THAT AN OCEAN WATER SEAL CHEST DRAIN DID NOT PROVIDE THE PROPER PRESSURE FOR THE CHEST TUBE. A SECOND DRAIN FROM A SECOND LOT NUMBER WAS OPENED AND THE SAME ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11503489 ↗
• MalfunctionMar 17, 2021Decrease in Suction; Decrease in Suction

  REPORT RECEIVED STATED THAT AN OCEAN WATER SEAL CHEST DRAIN DID NOT PROVIDE THE PROPER PRESSURE FOR THE CHEST TUBE. A SECOND DRAIN FROM A SECOND LOT NUMBER WAS OPENED AND THE SAME ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11503488 ↗
• MalfunctionFeb 9, 2021Device Difficult to Setup or Prepare

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11303024 ↗
• MalfunctionFeb 9, 2021Insufficient Device Problem Information

  N/A.

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

  MAUDE report 11302829 ↗
• MalfunctionJun 18, 2020Device Markings/Labelling Problem

  OCEAN CHEST DRAIN, SUCTION CONTROL CHAMBER WAS NOT DYED BLUE MAKING IT DIFFICULT TO DISCERN SUCTION WATER CHAMBER LEVEL. NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10168039 ↗
• MalfunctionMar 22, 2020Fluid/Blood Leak

  N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863748 ↗
• MalfunctionMar 22, 2020Fluid/Blood Leak

  REPORT RECEIVED STATED THE NURSE WALKED INTO PATIENT ROOM AND FOUND CHEST DRAIN HAD 2CC VOLUME IN CHAMBER AND WAS BUBBLING. THE DOCTOR ORDERED TO FILL DRAIN TO 10CC. SEVERAL HOURS LATER CHEST DRAIN FOUND ALMOST DRY. (NO PNEUMOTHORAX WAS NOTED).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863747 ↗
• MalfunctionMar 22, 2020Leak/Splash

  N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863746 ↗
• MalfunctionMar 22, 2020Material Discolored; Filling Problem; Appropriate Device Problem Term/Code Not Available

  THERE WAS NO WATER NOTED IN THE WATER SEAL CHAMBER WHEN ASSESSED IN THE MORNING. WATER WAS REPLACED. AT THE TIME OF WATER PLACEMENT WATER SEAL BALL WAS NOTED TO BE BLUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863743 ↗
• MalfunctionMar 21, 2020Fluid/Blood Leak

  REPORT RECEIVED STATED THAT UPON CHECKING THE CHEST TUBE/DRAIN THE DAY SHIFT NURSE FOUND THAT THE DRAIN WAS COMPLETELY DRY. THEY CONFIRMED THE DRAIN WAS LEAKING AND CHANGED IT OUT. NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863372 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem

  THE NURSES SAW NO BUBBLING IN THE AIR LEAK MONITOR, SO THEY REMOVED THE DRAIN. LATER THE PATIENT HAD A PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 9079976 ↗
• MalfunctionApr 19, 2019Tear, Rip or Hole in Device Packaging

  REPORT RECEIVED STATED THAT DAMAGE WAS NOTICED ON THE OUTER CARTON OF DRAIN IN STOCK. DRAIN WAS REMOVED AND REPLACED WITH NEW STOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8531041 ↗
• MalfunctionApr 16, 2019Tear, Rip or Hole in Device Packaging

  REPORT RECEIVED STATED THAT DAMAGE WAS NOTICED ON THE OUTER CARTON OF DRAIN IN STOCK. DRAIN WAS REMOVED AND REPLACED WITH NEW STOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8521192 ↗
• InjuryApr 16, 2019Tear, Rip or Hole in Device Packaging

  N/A.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8521187 ↗
• MalfunctionApr 16, 2019Tear, Rip or Hole in Device Packaging

  REPORT RECEIVED STATED THAT DAMAGE WAS NOTICED ON THE OUTER CARTON OF DRAIN IN STOCK. DRAIN WAS REMOVED AND REPLACED WITH NEW STOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8521184 ↗
• MalfunctionApr 16, 2019Break

  REPORT RECEIVED STATED THAT DAMAGE WAS NOTICED ON THE OUTER CARTON OF DRAIN IN STOCK. DRAIN WAS REMOVED AND REPLACED WITH NEW STOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8521147 ↗
• MalfunctionApr 16, 2019Break

  N/A.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8521146 ↗
• MalfunctionApr 16, 2019Leak/Splash

  REPORT RECEIVED STATED THAT THE DRAIN WAS BEING USED FOR A PROCEDURE AND IT STARTED LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8521145 ↗
• MalfunctionApr 16, 2019Tear, Rip or Hole in Device Packaging

  REPORT RECEIVED STATED THAT DAMAGE WAS NOTICED ON THE OUTER CARTON OF DRAIN IN STOCK. DRAIN WAS REMOVED AND REPLACED WITH NEW STOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8521143 ↗
• MalfunctionApr 16, 2019Break

  REPORT RECEIVED STATED THAT DAMAGE WAS NOTICED ON THE OUTER CARTON OF DRAIN IN STOCK. DRAIN WAS REMOVED AND REPLACED WITH NEW STOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8521142 ↗
• MalfunctionApr 12, 2019Noise, Audible

  RECEIVED A USER FACILITY REPORT (# (B)(4)) THAT STATES THE PATIENT HAD A CORONARY ARTERY BYPASS GRAFT (CABG). WHEN PATIENT ARRIVED TO ROOM AND WHILE SETTING UP THE CHEST TUBE SUCTIONS, A LOUD UNKNOWN NOISE WAS COMING FROM THE DRAIN. NO HARM TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511950 ↗

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-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-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-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-1935-2015 · May 7, 2015 · Terminated
  Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
• 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-1938-2015 · May 7, 2015 · Terminated
  EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
• Z-1959-2014 · Apr 28, 2014 · Terminated
  Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
• Z-0737-2014 · Nov 19, 2013 · Terminated
  Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the
• 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-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
• 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 5 more.