OCEANRecalls & reported problems across all models
Atrium Medical Corporation · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one OCEAN model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 111
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 4
We found 10 models of OCEAN by Atrium Medical Corporation in the FDA's device registry (GUDID). Together they are named in 111 adverse event reports in the FDA's MAUDE database, received between May 3, 2016 and Sep 15, 2022 — classified as 29 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (16 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
OCEAN recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 7 of these models · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported OCEAN problems
Device problems
- Suction Problem16
- Deformation Due to Compressive Stress14
- Material Deformation11
- Backflow7
- Material Twisted/Bent7
- Tear, Rip or Hole in Device Packaging7
- Device Operates Differently Than Expected6
- Fluid/Blood Leak5
Patient problems
- No Consequences Or Impact To Patient55
- No Information17
- No Known Impact Or Consequence To Patient14
- No Clinical Signs, Symptoms or Conditions9
- Pneumothorax8
- No Patient Involvement5
- Insufficient Information4
- No Code Available2
OCEAN models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OCEAN 2002-000BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- OCEAN 2002-400BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OCEAN 2002-300BOTTLE, COLLECTION, VACUUM1 recall10 reports
- OCEAN 2012-320BOTTLE, COLLECTION, VACUUM1 recall3 reports
- OCEAN 2050-000Apparatus, Autotransfusion1 recall2 reports
- OCEAN 2002-100BOTTLE, COLLECTION, VACUUM1 recall0 reports
- OCEAN 2002-040BOTTLE, COLLECTION, VACUUM1 recall0 reports
- OCEAN 2020-000BOTTLE, COLLECTION, VACUUM32 reports
- OCEAN 2020-100BOTTLE, COLLECTION, VACUUM1 report
- OCEAN 2050-300Apparatus, Autotransfusion1 report
Recent OCEAN adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionSep 6, 2022Fracture; Fracture
WHEN THE PATIENT GOT OUT OF BED AND MOVED AROUND AFTER THE OPERATION, THE CONNECT SITE BETWEEN THE CHEST DRAINAGE AND THE TISSUE CRACKED. THEN THE DOCTOR CHANGED ANOTHER ONE INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15362165 ↗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 12, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
REPORT RECEIVED STATED THAT DURING AN INSPECTION OF AN OASIS DRAIN IN THE WAREHOUSE IT WAS OBSERVED THAT THE TYVEK POUCH ON THE DRAIN HAD A HOLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 14089783 ↗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 ↗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 ↗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 ↗InjuryMay 5, 2021Missing Information; Missing Information
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 ↗InjuryMar 16, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
MalfunctionFeb 9, 2021Device Difficult to Setup or Prepare
MalfunctionFeb 9, 2021Insufficient Device Problem Information
N/A.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11302829 ↗MalfunctionFeb 2, 2021Tear, Rip or Hole in Device Packaging
MalfunctionAug 25, 2020Adverse Event Without Identified Device or Use Problem
Other Atrium Medical Corporation products
- ADVANTA SLIDER GDS51 models · 76 reports · 51 recalls
- FLIXENE SLIDER GDS17 models · 52 reports · 17 recalls
- PROLITE23 models · 515 reports
- OASIS6 models · 270 reports · 4 recalls
- PROLOOP12 models · 355 reports
- EXPRESS3 models · 142 reports · 4 recalls
- iCAST29 models · 197 reports
- C-QUR V-PATCH3 models · 165 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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