OASIS 3650-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00650862113013), received between Jan 31, 2017 and Dec 14, 2022 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (15 reports).

2 FDA recall records name this device's identifier, 2 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.

Recalls naming this device

1. 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 ↗

2. Sep 5, 2023Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF 15 UNITS. REFERENCE RELATED MDR: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976571 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF 15 UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976566 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF 15 UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976553 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF (B)(4) UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976552 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM#: 5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM#: 512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF 15 UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976547 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976545 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM#: 5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM#: 512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF (B)(4) UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976540 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF 15 UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976536 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF (B)(4) UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976531 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF 15 UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976381 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF (B)(4) UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976379 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM # 5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF (B)(4) UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976378 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF (B)(4) UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976376 ↗
• MalfunctionDec 14, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM#: 5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM#: 512404 (3600-100) DRAIN, SINGLE COLLECTION. THE CUSTOMER ALSO REPORTED THAT THE FULL LOT QUANTITY AFFECTED WAS A TOTAL OF 15 UNITS. REFERENCE RELATED MDR: 3011175548-2022-00411.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976370 ↗
• MalfunctionDec 13, 2022Nonstandard Device; Device Misassembled During Manufacturing /Shipping; Nonstandard Device; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED RECEIVING THE INCORRECT PRODUCT FOR ITEM #5303801 (3650-100) DRAIN OASIS DRY SUCTION BLOOD. THE PRODUCT INSIDE IS ITEM #512404 (3600-100) DRAIN, SINGLE COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968497 ↗
• MalfunctionSep 24, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem

  THE REPORT RECEIVED STATED THAT THE RED SUCTION BELLOWS OF THE OASIS DRAIN INDICATED THAT SUCTION WAS APPLIED AND FUNCTIONING. BUT THE REGULATOR WAS SET UP INCORRECTLY AND TOO LOW BY MISTAKE (-4= 30MMHG). FACILITY INQUIRED HOW COULD THE SUCTION STILL FUNCTION WITH THE LOW SETTING. THE INSTRUCTIONS FOR USE (IFU) STATES THAT THE SUCTION SOURCE SHOULD BE SET TO -80MMHG OR HIGHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530601 ↗
• MalfunctionJul 3, 2019No Flow

  N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761478 ↗
• InjuryJul 11, 2017Device Operates Differently Than Expected

  DURING PROCEDURE THE OASIS BRU DRAIN WAS BEING USED TO CAPTURE THE PATIENTS BLOOD IN ORDER TO BE RE-INFUSED WITH THEIR OWN BLOOD. A PART OF THE DRAIN MALFUNCTIONED AND THE BLOOD THAT WAS COLLECTED WAS UNABLE TO BE RE-INFUSED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6703667 ↗
• MalfunctionJun 11, 2017Device Slipped; Vibration; Connection Problem

  REPORT RECEIVED STATED THAT THE DRAINS DRY SUCTION REGULATOR SEEMED TO BE LOOSE AND NOT PROPERLY CONNECTED, AND THAT PART OF THE DRAIN WAS VIBRATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6632879 ↗
• MalfunctionJun 11, 2017Loose or Intermittent Connection; Connection Problem

  REPORT RECEIVED STATED THAT THE DRAINS DRY SUCTION REGULATOR SEEMED TO BE LOOSE AND NOT PROPERLY CONNECTED, AND THAT PART OF THE DRAIN WAS VIBRATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6632877 ↗
• MalfunctionJun 11, 2017Loose or Intermittent Connection; Vibration

  REPORT RECEIVED STATED THAT THE DRAINS DRY SUCTION REGULATOR SEEMED TO BE LOOSE AND NOT PROPERLY CONNECTED, AND THAT PART OF THE DRAIN WAS VIBRATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6632875 ↗
• InjuryJan 31, 2017Fluid/Blood Leak

  REPORT RECEIVED STATED THAT DURING OPERATION OF A DRAIN IT WAS NOTICED THAT BLOOD WAS LEAKING ONTO THE FLOOR AND ON FRONT OF DRAIN.

  Patient problems: No Information

  MAUDE report 6289887 ↗