OASIS 3600-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00650862110036), received between Feb 25, 2021 and Feb 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Reflux within Device” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2021No Apparent Adverse Event; Reflux within Device; No Apparent Adverse Event

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 11382730 ↗

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-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-0318-2024 · Sep 18, 2023 · Open, Classified
  Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
• 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-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-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-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-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-0738-2014 · Nov 19, 2013 · Terminated
  Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air a
• Z-0737-2014 · Nov 19, 2013 · Terminated
  Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the

…and 8 more.