OASIS 3612-100Recalls & reported problems
Atrium Medical Corporation · Atrium Oasis Chest Drain Infant/Pediatric Collection Dry Suction Water Seal · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00650862111019), received between Jun 13, 2019 and Apr 28, 2026 — classified as 4 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (4 reports).
1 FDA recall record name this device's identifier, 1 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
- 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 ↗
Most reported problems
Device problems
- Product Quality Problem4
- Adverse Event Without Identified Device or Use Problem2
- Overfill2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Calibration Problem1
- Component Missing1
- Component or Accessory Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient5
- Pneumothorax2
- Aspiration Pneumonitis1
- Insufficient Information1
- Low Oxygen Saturation1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Adverse Event Without Identified Device or Use Problem
THE OASIS DRAIN WAS REPLACED DUE TO A PNEUMOTHORAX THAT WAS NOT RESOLVING AS EXPECTED. FOLLOWING REPLACEMENT WITH ANOTHER OASIS DRAIN, A LACK OF VIGOROUS BUBBLING WAS OBSERVED, HOWEVER THE PATIENT REMAINED CLINICALLY STABLE. REVIEW CONFIRMED THE PRESENCE OF A SMALL AIR LEAK WITH APPROPRIATE DEVICE FUNCTION. A SUBSEQUENT CHEST XRAY DEMONSTRATED IMPROVEMENT IN THE PNEUMOTHORAX. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014706 ↗MalfunctionApr 23, 2026Adverse Event Without Identified Device or Use Problem
THE OASIS DRAIN WAS REPLACED DUE TO A PNEUMOTHORAX THAT WAS NOT RESOLVING AS EXPECTED. FOLLOWING REPLACEMENT WITH ANOTHER OASIS DRAIN, A LACK OF VIGOROUS BUBBLING WAS OBSERVED, HOWEVER THE PATIENT REMAINED CLINICALLY STABLE. REVIEW CONFIRMED THE PRESENCE OF A SMALL AIR LEAK WITH APPROPRIATE DEVICE FUNCTION. A SUBSEQUENT CHEST XRAY DEMONSTRATED IMPROVEMENT IN THE PNEUMOTHORAX. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24961597 ↗MalfunctionMay 29, 2025Inadequate Instructions for Healthcare Professional; Component or Accessory Incompatibility; Inadequate Instructions for Healthcare Professional; Component or Accessory Incompatibility
MalfunctionMar 19, 2025Missing Information; Missing Information
IT WAS REPORTED THAT WHILE USING AN OASIS PEDIATRIC DRAIN ON A PATIENT THE DOCTOR AND NURSING STAFF WERE CONFUSED WITH DRY SUCTION/WET SEAL ON THE DRAIN AS THEY WANTED TO KNOW THE PROCESS TO CONVERT THE DRAIN TO WET SEAL FROM SUCTION AND THE STEPS NEEDED TO BE TAKEN. ONLY INSTRUCTIONS WITH THE DRAIN WAS PICTURES OF AN OASIS DRAIN NO WRITTEN INSTRUCTIONS OR DETAILS FOR DOCTOR AND NURSING STAFF TO REVIEW. DRAIN WAS SET UP PROPERLY. NO HARM OR INJURY REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21649449 ↗InjuryJan 13, 2025Overfill; Overfill
PICU RN CALLED FOR ASSISTANCE WITH ATRIUM OASIS PEDIATRIC DRAIN. INFANT HAD BEEN ADMITTED FOR PNEUMOTHORAX AND HAD A CHEST TUBE PLACED. PATIENT THEN DEVELOPED A LARGER PNEUMOTHORAX BELOW THE FIRST, SO A SECOND CHEST TUBE WAS PLACED AFTER NEEDLE ASPIRATION. THE CALLER DESCRIBED THAT THE BLUE WATER IN THE AIR LEAK MONITOR CHAMBER C OF THE SECOND CHEST DRAIN HAD OVERFILLED TO WATER SEAL CHAMBER B, MEANING THAT THERE WAS AN ACUTE RISE IN THE WATER SEAL CHAMBER LEVEL. THE DRAIN WAS CHANGED OUT AND THE SAME THING WAS OBSERVED ON THE REPLACEMENT DRAIN. SUPPORT TEAM DISCUSSED WITH THE CALLER THAT THIS COULD BE INDICATIVE OF A RISE IN THE PATIENT¿S INTRATHORACIC PRESSURE, AND POSSIBLE CLINICAL REASONS. NO DRAINAGE WAS OBSERVED IN COLLECTION CHAMBER D. AFTER REPEAT CHEST XRAY IT WAS DETERMINED THAT THE PATIENT¿S PNEUMOTHORAX HAD INCREASED IN SIZE AND CARE TEAM ATTEMPTED ASPIRATION FROM THE CHEST TUBE. REPORTEDLY RESISTANCE WAS ENCOUNTERED DURING ASPIRATION, BUT EVERYTHING RETURNED TO NORMAL ONCE THE DRAIN WAS RECONNECTED.
Patient problems: Pneumothorax
MAUDE report 21146421 ↗InjuryJan 9, 2025Overfill; Overfill
PICU RN CALLED FOR ASSISTANCE WITH ATRIUM OASIS PEDIATRIC DRAIN. INFANT HAD BEEN ADMITTED FOR PNEUMOTHORAX AND HAD A CHEST TUBE PLACED. PATIENT THEN DEVELOPED A LARGER PNEUMOTHORAX BELOW THE FIRST, SO A SECOND CHEST TUBE WAS PLACED AFTER NEEDLE ASPIRATION. THE CALLER DESCRIBED THAT THE BLUE WATER IN THE AIR LEAK MONITOR CHAMBER C OF THE SECOND CHEST DRAIN HAD OVERFILLED TO WATER SEAL CHAMBER B, MEANING THAT THERE WAS AN ACUTE RISE IN THE WATER SEAL CHAMBER LEVEL. THE DRAIN WAS CHANGED OUT AND THE SAME THING WAS OBSERVED ON THE REPLACEMENT DRAIN. SUPPORT TEAM DISCUSSED WITH THE CALLER THAT THIS COULD BE INDICATIVE OF A RISE IN THE PATIENT¿S INTRATHORACIC PRESSURE, AND POSSIBLE CLINICAL REASONS. NO DRAINAGE WAS OBSERVED IN COLLECTION CHAMBER D. AFTER REPEAT CHEST XRAY IT WAS DETERMINED THAT THE PATIENT¿S PNEUMOTHORAX HAD INCREASED IN SIZE AND CARE TEAM ATTEMPTED ASPIRATION FROM THE CHEST TUBE. REPORTEDLY RESISTANCE WAS ENCOUNTERED DURING ASPIRATION, BUT EVERYTHING RETURNED TO NORMAL ONCE THE DRAIN WAS RECONNECTED.
Patient problems: Pneumothorax
MAUDE report 21110803 ↗MalfunctionAug 25, 2023Product Quality Problem; Product Quality Problem
MalfunctionAug 25, 2023Product Quality Problem; Product Quality Problem
REPORT RECEIVED STATED THAT THE CUSTOMER HAS A PEDI OASIS DRAIN THAT HAS A WET-LOOKING SPOT WHERE THE STICKY DOT (THAT HOLDS THE BLUE CAP IN PLACE) HAS ¿LIQUEFIED¿ SOME, AND BLED THROUGH ONTO THE OUTER SIDE OF THE SLEEVE. IT IS SHOWING THROUGH ONTO THE OUTER PORTION OF THE PAPER, APPEARING WET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17623264 ↗MalfunctionAug 25, 2023Product Quality Problem; Product Quality Problem
MalfunctionAug 22, 2023Product Quality Problem; Product Quality Problem
REPORT RECEIVED STATED THAT THE CUSTOMER HAS A PEDI OASIS DRAIN THAT HAS A WET-LOOKING SPOT WHERE THE STICKY DOT (THAT HOLDS THE BLUE CAP IN PLACE) HAS ¿LIQUEFIED¿ SOME, AND BLED THROUGH ONTO THE OUTER SIDE OF THE SLEEVE. IT IS SHOWING THROUGH ONTO THE OUTER PORTION OF THE PAPER, APPEARING WET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17600122 ↗InjuryJun 28, 2023Device Handling Problem; Device Handling Problem
MalfunctionFeb 4, 2022Appropriate Device Problem Term/Code Not Available; Component Missing; Appropriate Device Problem Term/Code Not Available
RECEIVED A USER FACILITY MDR REPORT (3633050000-2021-8033) ON (B)(6) 2022. THE REPORT RECEIVED STATED THAT THE BLUE CAPS WERE MISSING FROM CT DRAINAGE DEVICE. ITEM DISCARDED, ONE FROM SAME LOT NUMBER WAS AVAILABLE. NOTE: THE RESULTS FROM THE DECISION TREE STATE THAT THE EVENT IS NOT REPORTABLE. SINCE THE COMPLAINT WAS OPENED DUE TO A FDA MEDWATCH FORM RECEIVED, THE COMPLAINT IS BEING REPORTED TO THE FDA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13455983 ↗InjuryOct 5, 2021Insufficient Device Problem Information; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information
MalfunctionMar 27, 2020Suction Problem
NURSE REPORTED THAT OVER THE WEEKEND SHE COULD NOT TURN UP THE SUCTION DIAL FROM -20CMH2O UP TO -30CMH2O. THERE WAS NO IMPACT TO THE PATIENT AND ANOTHER DRAIN WAS ATTACHED WHICH WORKED CORRECTLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9889475 ↗MalfunctionMar 27, 2020Break; Physical Resistance/Sticking
NURSE EDUCATOR REPORTED THEY CHECKED THE SAMPLE USED FOR TRAINING AND THE REGULATOR WAS STUCK. THEY FORCIBLY TURNED THE DIAL AND IT BROKE. DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9889470 ↗MalfunctionMar 27, 2020Calibration Problem
NURSE REPORTED THAT OVER THE WEEKEND SHE COULD NOT TURN UP THE SUCTION DIAL FROM -20CMH2O UP TO -30CMH2O. THERE WAS NO IMPACT TO THE PATIENT AND ANOTHER DRAIN WAS ATTACHED WHICH WORKED CORRECTLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9889395 ↗MalfunctionOct 22, 2019Fluid/Blood Leak
MalfunctionJun 13, 2019Leak/Splash
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.