OASIS 3612-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00650862111026), received between Jul 6, 2016 and Jul 6, 2016 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (2 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2016Insufficient Flow or Under Infusion

  REPORT RECEIVED STATED THAT AN OASIS DRAIN WOULD NOT EVACUATE AIR WHEN CONNECTED TO THE PATIENT. THE BELLOWS APPEARED NOT TO COMPLETELY EXPAND TO THE INDICATOR MARK OR BEYOND AS STATED IN THE INSTRUCTIONS FOR USE (IFU). ANOTHER CHEST TUBE AND DRAIN FROM A DIFFERENT LOT WAS USED WITHOUT ANY ISSUES.

  Patient problems: No Information

  MAUDE report 5774265 ↗
• InjuryJul 6, 2016Improper Device Output

  REPORT RECEIVED STATED THAT AN OASIS DRAIN WOULD NOT EVACUATE AIR WHEN CONNECTED TO THE PATIENT. THE BELLOWS APPEARED NOT TO COMPLETELY EXPAND TO THE INDICATOR MARK OR BEYOND AS STATED IN THE INSTRUCTIONS FOR USE (IFU). ANOTHER CHEST TUBE AND DRAIN FROM A DIFFERENT LOT WAS USED WITHOUT ANY ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5774260 ↗
• InjuryJul 6, 2016Insufficient Flow or Under Infusion; Device Operates Differently Than Expected; Activation Failure

  REPORT RECEIVED STATED THAT AN OASIS DRAIN WOULD NOT EVACUATE AIR WHEN CONNECTED TO THE PATIENT. THE BELLOWS APPEARED NOT TO COMPLETELY EXPAND TO THE INDICATOR MARK OR BEYOND AS STATED IN THE INSTRUCTIONS FOR USE (IFU). ANOTHER CHEST TUBE AND DRAIN FROM A DIFFERENT LOT WAS USED WITHOUT ANY ISSUES.

  Patient problems: No Information

  MAUDE report 5774254 ↗

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-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-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-1935-2015 · May 7, 2015 · Terminated
  Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
• Z-1938-2015 · May 7, 2015 · Terminated
  EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
• Z-1959-2014 · Apr 28, 2014 · Terminated
  Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
• Z-0743-2014 · Nov 19, 2013 · Terminated
  Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the
• 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

…and 8 more.