OASISRecalls & reported problems across all models
Atrium Medical Corporation · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name at least one OASIS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 270
- Deaths reported
- 1
- Injuries reported
- 41
- Recalls
- 4
We found 6 models of OASIS by Atrium Medical Corporation in the FDA's device registry (GUDID). Together they are named in 270 adverse event reports in the FDA's MAUDE database, received between Apr 28, 2016 and Sep 23, 2026 — classified as 1 death, 41 injuries, 228 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (31 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
Reports received per month, all models
OASIS 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.
- Nov 1, 2023Class IIOpen, 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 · Recall details · FDA record ↗
- Sep 18, 2023Class IIOpen, 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 · names 3 of these models · Recall details · FDA record ↗
- Sep 5, 2023Class IIOpen, 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-0486-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Sep 5, 2023Class IIOpen, 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 · Recall details · FDA record ↗
Most reported OASIS problems
Device problems
- Deformation Due to Compressive Stress31
- Device Damaged Prior to Use23
- Device Misassembled During Manufacturing /Shipping15
- Nonstandard Device15
- Crack13
- Fluid/Blood Leak13
- Suction Problem13
- Leak/Splash12
Patient problems
- No Clinical Signs, Symptoms or Conditions138
- No Known Impact Or Consequence To Patient33
- No Consequences Or Impact To Patient22
- No Patient Involvement22
- No Information20
- Pneumothorax13
- Insufficient Information10
- Pain5
OASIS models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OASIS 3600-100Bottle, Collection, Vacuum3 recalls1 death175 reports
- OASIS 3650-100APPARATUS, AUTOTRANSFUSION2 recalls22 reports
- OASIS 3612-100Bottle, Collection, Vacuum1 recall18 reports
- OASIS 3620-100Bottle, Collection, Vacuum51 reports
- OASIS 3612-400Bottle, Collection, Vacuum3 reports
- OASIS 3600-150APPARATUS, AUTOTRANSFUSION1 report
Recent OASIS adverse event reports
The 15 most recent reports across all models, 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
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 ↗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 ↗
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
- PROLOOP12 models · 355 reports
- EXPRESS3 models · 142 reports · 4 recalls
- OCEAN10 models · 111 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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