OASIS 3600-100Recalls & reported problems
Atrium Medical Corporation · Atrium Oasis Dry Suction Water Seal Chest Drain · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Atrium Oasis chest drain has 174 adverse event reports, with 1 death and 26 injuries. The reports mostly describe cracks, leaks, and weak suction, with some units damaged before use. Three recalls name this device, all open: they cover a sterilization problem that made label expiry dates inaccurate, unclear setup instructions, and units reprocessed by a third party.
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
- 175
- Deaths reported
- 1
- Injuries reported
- 26
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 00650862110012), received between Apr 28, 2016 and Sep 23, 2026 — classified as 1 death, 26 injuries, 148 malfunctions.
The most frequently reported specific device problem is “Crack” (13 reports).
3 FDA recall records name this device's identifier, 3 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Nov 1, 2023Open, Classified
A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
Z-0621-2024 · Root cause: Nonconforming Material/Component · FDA record ↗
- 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-0317-2024 · Root cause: Error in labeling · FDA record ↗
- Sep 5, 2023Open, Classified
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
Z-0485-2024 · Root cause: Labeling mix-ups · FDA record ↗
Most reported problems
Device problems
- Crack13
- Fluid/Blood Leak11
- Leak/Splash11
- Suction Problem11
- Use of Device Problem10
- Device Damaged Prior to Use9
- Decrease in Suction7
- Adverse Event Without Identified Device or Use Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions92
- No Known Impact Or Consequence To Patient21
- No Information15
- No Consequences Or Impact To Patient13
- Pneumothorax9
- Insufficient Information8
- No Patient Involvement7
- Pain5
Recent adverse event reports
The 25 most recent of 175 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Device Tipped Over
The user reported that while using the Oasis Drain, the device was accidentally knocked over. The user denied experiencing shortness of breath, increased work of breathing, or chest pain. The user also stated that the drainage had moved to "the other side of the drain."Following review of the provided photograph by the ESP team, brown fluid was observed in the Water Seal/Air Leak Monitor window and Water Seal Column, with the fluid level exceeding the intended 2 cm water seal level. No patient harm or adverse event was reported
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867173 ↗MalfunctionAug 30, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50513344 ↗MalfunctionAug 12, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225249 ↗MalfunctionJul 28, 2026Gas/Air Leak
MalfunctionJul 28, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054367 ↗MalfunctionJul 28, 2026Device Tipped Over
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50053314 ↗MalfunctionMay 3, 2026Device Contaminated During Manufacture or Shipping
MalfunctionFeb 26, 2026Break
MalfunctionFeb 26, 2026Break
MalfunctionFeb 26, 2026Break
MalfunctionFeb 13, 2026Deformation Due to Compressive Stress
IT WAS REPORTED THAT PRIOR TO USE, OASIS DRAIN TUBING WAS FOUND TO BE COMPRESSED. THE COMPRESSED SECTION WAS CUT OUT AND REPLACED WITH AN ADAPTER TO MAINTAIN REQUIRED LENGTH. THERE WAS NO PATIENT INVOLVED AND NO ADVERSE EVENT REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334690 ↗MalfunctionFeb 2, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE OASIS DRAIN DID NOT FUNCTION AFTER BEING CONNECTED TO THE PATIENT. THE ICC SITE AND DRESSING WERE INTACT. STAFF REPLACED THE UNIT, AND THE NEW DRAIN WORKED PROPERLY. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232877 ↗MalfunctionJan 12, 2026Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING USE, THE SUCTION PORT OF OASIS DRAIN SEEMS TO BE COLLAPSING AND IMPACTING THE SUCTION. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032143 ↗MalfunctionDec 18, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING USE THE OASIS CHEST DRAIN, IT WAS FOUND TO BE DAMAGED. THERE WAS NO ADVERSE EVENT OR HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23836608 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionDec 18, 2025Installation-Related Problem; Installation-Related Problem
ADDITIONALLY IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23836320 ↗MalfunctionAug 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A FAILURE OCCURRED WITH AN OASIS CHEST DRAIN, DRY SUCTION WATER SEAL. THE PATIENT'S CHEST TUBE HAD BODILY FLUID SPILLING INTO THE WATER SEAL. THE CHEST TUBE WAS REPLACED AND THERE WAS NO REPORTED HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22846472 ↗InjuryJul 25, 2025Suction Problem; Suction Problem
IT WAS REPORTED THAT POST OPEN HEART SURGERY PATIENT WAS MOVED TO CICU WITH ALL THREE CHEST TUBES CONNECTED TO THE SAME SUCTION CANISTER AND IT WAS OBSERVED THAT PATIENT'S BLOOD PRESSURE STARTED TO DROP TO 60S/30S FROM 80S/50S. PATIENT CONTINUED TO DECOMPENSATE WITH WORSENING VITALS AND EXAM. CHEST TUBES WAS STRIPPED AND IRRIGATED AND ECMO WAS USED. AS THE PATIENT'S PATCH OVER OPEN CHEST WAS BULGING, THE DOCTOR TOOK THE PATCH DOWN AND SUCTIONED OUT BLOOD AND CLOTS FROM AROUND THE HEART. THE PATIENT'S VITALS STABILIZED, THEIR COLOR AND PULSES IMPROVED. THE MEDIASTINAL CHEST TUBE WAS NOT SUCTIONING APPROPRIATELY AND CHEST TUBES WAS TROUBLESHOOTED BY REPLACING SUCTION TUBING FOR EACH CHEST TUBE AND CONNECT EACH SUCTION TUBING TO IT'S OWN INDIVIDUAL SUCTION CANISTER. THE SUCTION FOR THE MEDIASTINAL CHEST TUBE THEN WORKED CORRECTLY AND SUCTIONING BLOOD FROM AROUND THE HEART. THE PATIENT NO LONGER NEEDED ECMO AND THEN THE DOCTOR PLACED A PATCH AND IOBAN BACK OVER THE OPEN CHEST.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 22609601 ↗MalfunctionJul 15, 2025Component Missing; Component Missing
MalfunctionJun 27, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE OASIS DRAIN PACKAGE WAS OPEN, SO NOT STERILE AND NOT USED. REPLACED WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22347120 ↗MalfunctionJun 11, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
MalfunctionMay 29, 2025Inadequate Instructions for Healthcare Professional; Component or Accessory Incompatibility; Inadequate Instructions for Healthcare Professional; Component or Accessory Incompatibility
MalfunctionMay 21, 2025Fluid/Blood Leak; Fracture; Suction Problem; Material Split, Cut or Torn; Incomplete or Inadequate Connection; Fluid/Blood Leak; Fracture; Suction Problem; Material Split, Cut or Torn; Incomplete or Inadequate Connection
REPORT RECEIVED STATED THAT AN OASIS CHEST DRAIN HAD HOLES IN THE TUBING. AFTER HOOKING IT TO THE PATIENT AND IT WAS FOUND THAT THERE WERE HOLES IN THE TUBING. WHEN THEY COULD NOT CREATE SUCTION, IT WAS REMOVED. THERE WAS NO HARM OR PATIENT INJURY, THE DRAIN WAS REPLACED AND HAD NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22065828 ↗MalfunctionMay 21, 2025Suction Problem; Suction Problem
REPORT RECEIVED STATED THAT DURING USE WHEN THE PATIENT TOOK A BREATH THE FLOAT BALL ON AN OASIS DRAIN HAD NO OSCILLATION ON OR OFF WALL SUCTION. THERE WAS NO HARM OR PATIENT INJURY. IT WAS RECOMMENDED TO THE NURSE TO GET A CHEST X-RAY PERFORMED IN ORDER TO ASSESS THE PATIENT¿S PNEUMOTHORAX AND REPORT THE FINDINGS TO THE PHYSICIAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22065354 ↗
Other Bottle, Collection, Vacuum devices
- 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
- OCEAN 2002-300Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall10 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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