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OASIS 3620-100Recalls & reported problems

Atrium Medical Corporation · OASIS DRAIN, DUAL, IN-LINE, ATS COMPATIBLE · Class 2

All models of OASIS (6)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Atrium OASIS dual in-line chest drain is a vacuum bottle used to collect fluid from the chest. Most of its 51 reports describe the silicone coming out of the package already kinked or bent so it does not drain properly, plus units damaged before use and some that were hard to remove. Six reports mention injuries and none mention deaths. No recalls name this device.

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
51
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00650862112016), received between Feb 17, 2017 and Jul 28, 2022 — classified as 6 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (26 reports).

23 other recalls cover devices cleared under the same FDA submission (K043140); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Deformation Due to Compressive Stress26
  • Device Damaged Prior to Use14
  • Difficult to Remove5
  • Material Integrity Problem4
  • Material Twisted/Bent4
  • Material Deformation3
  • Contamination /Decontamination Problem1
  • Difficult to Open or Close1

Patient problems

  • No Clinical Signs, Symptoms or Conditions21
  • No Patient Involvement15
  • No Known Impact Or Consequence To Patient7
  • No Consequences Or Impact To Patient3
  • Pneumothorax2
  • Insufficient Information1
  • No Information1
  • Therapeutic Response, Decreased1

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 28, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15127089 ↗
  • MalfunctionJul 26, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15109069 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15100047 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15100019 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15100017 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15099987 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15098837 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15098053 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15098050 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15097967 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15097503 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: Insufficient Information

    MAUDE report 15095134 ↗
  • MalfunctionJul 25, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15095059 ↗
  • MalfunctionJul 21, 2022Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

    ESPECIALLY FOR THE DUAL OASIS CHEST DRAINS, THEY ARE KINKED FROM THE BEGINNING WHEN OPENED FROM THE PACKAGE. SILICONE IS NOT RETURNING INTO ITS ORIGINAL SHAPE SO SOME CUSTOMERS COMPLAIN SAYING IT DOES NOT THE DRAIN EFFICIENTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15074823 ↗
  • MalfunctionApr 12, 2022Increase in Suction; Increase in Suction

    REPORT RECEIVED STATED THAT DURING THE POSTOPERATIVE PERIOD OF THE PATIENT THE OASIS DRAIN WAS OBSERVED TO HAVE BUBBLING AND PRESENCE OF BLOOD IN THE WATER SEAL CHAMBER. NO PATIENT INJURIES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14089891 ↗
  • MalfunctionFeb 21, 2022Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

    CUSTOMER REPORTS THAT PATIENT TUBING IS WARPED/PINCHED, PREVENTING PROPER SUCTION/DRAINAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13572928 ↗
  • MalfunctionFeb 3, 2022Material Twisted/Bent; Material Twisted/Bent

    CUSTOMER HAS INDICATED THAT THE DRAIN THEY RECEIVED THE TUBING WAS WARPED/PINCHED RENDERING IT UNABLE TO BE USED FOR SUCTION OR DRAINAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13447744 ↗
  • MalfunctionFeb 2, 2022Material Twisted/Bent; Material Twisted/Bent

    N/A.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13429463 ↗
  • MalfunctionJan 28, 2022Material Integrity Problem; Material Integrity Problem

    N/A.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13389653 ↗
  • MalfunctionJan 28, 2022Material Integrity Problem; Material Integrity Problem

    N/A.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13389652 ↗
  • MalfunctionJan 28, 2022Material Integrity Problem; Material Integrity Problem

    REPORT RECEIVED STATED THAT THE TUBE WAS KINKED ON THE ATRIUM DRAIN, DRY DUAL W/AC.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13389651 ↗
  • MalfunctionJan 28, 2022Material Integrity Problem; Material Integrity Problem

    REPORT RECEIVED STATED THAT THE TUBE WAS KINKED ON THE ATRIUM DRAIN, DRY DUAL W/AC.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13386415 ↗
  • MalfunctionAug 21, 2020Contamination /Decontamination Problem

    RECEIVED EMAIL FROM OPERATING ROOM DIRECTOR A DRAIN WAS OPENED AND A HAIR WAS ON THE DRAIN. THE DRAIN WAS NOT USED.

    Patient problems: No Patient Involvement

    MAUDE report 10440426 ↗
  • InjuryJan 16, 2020Material Twisted/Bent

    REPORT RECEIVED STATED THAT UPON OPENING THE DRAIN A PERMANENT KINK WAS NOTICED ON THE PATIENT TUBE. PRODUCT WAS NOT USED.

    Patient problems: No Patient Involvement

    MAUDE report 9596524 ↗
  • InjuryJan 14, 2020Material Deformation

    ON PATIENT CONNECTION THE TUBE OF THE DRAIN WAS NOTICED TO HAVE A PERMANENT KINK.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9587429 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043140. One submission often covers many models, so check the product and lot details in each record.

  • Z-0709-2024 · Dec 13, 2023 · Open, Classified
    Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
  • Z-0621-2024 · Nov 1, 2023 · Open, Classified
    Atrium Oasis Drain Single W / AC, Part No. 3600-100
  • Z-0318-2024 · Sep 18, 2023 · Open, Classified
    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
  • Z-0317-2024 · Sep 18, 2023 · Open, Classified
    Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
  • Z-0485-2024 · Sep 5, 2023 · Open, Classified
    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
  • Z-1207-2017 · Dec 23, 2016 · Terminated
    Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To he
  • Z-1211-2017 · Dec 23, 2016 · Terminated
    Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establ
  • Z-1208-2017 · Dec 23, 2016 · Terminated
    Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help
  • 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-1935-2015 · May 7, 2015 · Terminated
    Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
  • Z-1959-2014 · Apr 28, 2014 · Terminated
    Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
  • Z-0739-2014 · Nov 19, 2013 · Terminated
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the
  • Z-0742-2014 · Nov 19, 2013 · Terminated
    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.

…and 8 more.

Other Bottle, Collection, Vacuum devices

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Sources and updates

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