EXPRESS 4000-100NRecalls & reported problems
Atrium Medical Corporation · Atrium Express Chest Drain Single Collection Dry Suction Dry Seal · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Atrium Express 4000-100N is a vacuum collection bottle used as a chest drain to remove fluid and air from around the lungs. The 30 reports mostly describe cracked or deformed plastic, air leaks, missing water in the leak chamber, and setup or handling difficulties. No deaths and 7 injuries were reported. Two open recalls, both from 2023, cover syringes packed with the drain that may not be sterile if the pack is not kept upright, and labeling that does not explain proper setup of the catheter and tubing.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00650862115130), received between Feb 24, 2017 and Feb 9, 2024 — classified as 7 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Crack” (5 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.
Reports received per month
Recalls naming this device
- Dec 13, 2023Open, Classified
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Z-0709-2024 · Root cause: Material/Component Contamination · FDA record ↗
- 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-0318-2024 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Crack5
- Improper or Incorrect Procedure or Method5
- Gas/Air Leak4
- Contamination /Decontamination Problem3
- Adverse Event Without Identified Device or Use Problem2
- Deformation Due to Compressive Stress2
- Use of Device Problem2
- Component Missing1
Patient problems
- No Known Impact Or Consequence To Patient10
- No Patient Involvement7
- No Information6
- No Clinical Signs, Symptoms or Conditions4
- Respiratory Distress2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem
EMT CALLED WITH QUESTIONS ON HOW TO CHANGE OUT AN ATRIUM EXPRESS CHEST DRAIN. THE PATIENT HAD BEEN SENT HOME FROM THE HOSPITAL EARLIER THAT DAY WITH A CHEST DRAIN TUBE ATTACHED TO AN ATRIUM EXPRESS FULL SIZE CHEST DRAIN. THE PATIENT AND FAMILY HAD NOT RECEIVED ANY TEACHING OF HOW TO CHANGE OUT THE CHEST DRAIN WHEN IT BECAME FULL. HOWEVER, THEY WERE SENT HOME WITH SEVERAL ADDITIONAL DRAINS. I REVIEWED THE PROCEDURE IN DETAIL. BY AT THE TIME THE CALL ENDED THEY HAD MADE THE DECISION TO TAKE THE PATIENT BACK TO THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18676626 ↗MalfunctionOct 31, 2022Packaging Problem; Packaging Problem
MalfunctionAug 12, 2021Leak/Splash; Use of Device Problem; Device Tipped Over; Use of Device Problem; Device Tipped Over
REPORT RECEIVED STATED THAT AFTER CONNECTION OF AN EXPRESS DRAIN IT WAS NOTED THAT THERE WAS NO WATER IN THE AIR LEAK CHAMBER (C). THE SUCTION WAS TURNED OFF AND THE CHEST DRAIN CLAMPED, WATER WAS THEN ADDED TO (C) AND IT WAS THEN NOTICED THAT THERE WAS FLUID NEAR THE REGULATOR (E) OF THE DRAINAGE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12312880 ↗MalfunctionMay 4, 2021Disconnection; Disconnection
MalfunctionMar 25, 2021Contamination; Contamination /Decontamination Problem; Contamination
MalfunctionAug 31, 2020Crack; Crack
RECEIVED REPORT THAT UPON OPENING THE DRAIN PACKAGE THE DRAIN WAS FOUND TO BE CRACKED ON THE TOP. PRODUCT WAS NOT USED ON PATIENT.
Patient problems: No Patient Involvement
MAUDE report 10475113 ↗MalfunctionAug 31, 2020Crack; Crack
MalfunctionAug 31, 2020Crack; Crack
RECEIVED REPORT THAT UPON OPENING THE DRAIN PACKAGE THE DRAIN WAS FOUND TO BE CRACKED ON THE TOP. PRODUCT WAS NOT USED ON PATIENT.
Patient problems: No Patient Involvement
MAUDE report 10475086 ↗MalfunctionAug 31, 2020Crack; Crack
MalfunctionAug 31, 2020Crack; Crack
RECEIVED REPORT THAT UPON OPENING THE DRAIN PACKAGE THE DRAIN WAS FOUND TO BE CRACKED ON THE TOP. PRODUCT WAS NOT USED ON PATIENT.
Patient problems: No Patient Involvement
MAUDE report 10474162 ↗InjuryMar 15, 2020Adverse Event Without Identified Device or Use Problem
REPORT RECEIVED STATED THAT A CARDIAC SURGERY PATIENT WITH CHRONIC EMPHYSEMA WAS HAVING TROUBLE BREATHING POST-OP IN THE ICU. NURSING STAFF THOUGHT THERE MIGHT BE SOMETHING WRONG WITH THE 4000-100N DRAIN. THEY SWAPPED OUT THE DRAIN AND HIS CONDITION IMPROVED.
Patient problems: Respiratory Distress
MAUDE report 9833226 ↗InjuryMar 15, 2020Adverse Event Without Identified Device or Use Problem
Patient problems: Respiratory Distress
MAUDE report 9833184 ↗MalfunctionAug 1, 2019Fitting Problem
IT WAS REPORTED THAT THE CHEST DRAIN TUBE AND CONNECTOR DID NOT FIT THE 20FR TROCAR USES AS THE TROCAR WAS THE SAME SIZE AS THE CHEST DRAIN TUBE. THE PRODUCT WAS NOT DEFECTIVE, HOWEVER THE COMPONENTS PROVIDED WERE NOT ADEQUATE.
Patient problems: No Information
MAUDE report 8851034 ↗MalfunctionJul 23, 2019Component Missing
MalfunctionJul 19, 2019Material Deformation
CUSTOMER HAS COMPLAINED THAT TUBING IS KINKED SINCE PACKAGING HAS BEEN CHANGED. PATIENTS ARE BEING TRANSFERRED FROM THEATRE TO INTENSIVE CARE UNIT (ICU) AND DRAINS ARE KINKING
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8809280 ↗MalfunctionJul 19, 2019Deformation Due to Compressive Stress
MalfunctionJul 19, 2019Deformation Due to Compressive Stress
MalfunctionApr 5, 2019Contamination /Decontamination Problem
IT WAS REPORTED THAT UPON OPENING THE DRAIN, A BROWN DOT WAS NOTICED ON THE PLASTIC HOLDER THAT ATTACHES THE SYRINGE TO THE PRODUCT..
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8489066 ↗MalfunctionMar 26, 2019Contamination /Decontamination Problem
MalfunctionDec 3, 2018Gas/Air Leak
REPORT RECEIVED STATED THAT THE CHEST DRAIN WAS SETUP AND CONNECTED TO THE PATIENT IN ACCORDANCE WITH THE INSTRUCTION FOR USE. AFTER CONNECTING THE SUCTION LINE TO THE DRAIN, THE CUSTOMER NOTICED A SIGNIFICANT AIR LEAK AS INDICATED BY THE AIR LEAK MONITOR. THE SURGEON CONFIRMED WITH THE ANESTHESIOLOGIST THAT THERE WASN'T AN AIR LEAK IN THE LUNG.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8125022 ↗MalfunctionDec 3, 2018Gas/Air Leak
MalfunctionDec 3, 2018Gas/Air Leak
MalfunctionDec 3, 2018Gas/Air Leak
MalfunctionJul 23, 2018Tear, Rip or Hole in Device Packaging
REPORT STATED THAT A SMALL HOLE WAS FOUND ON THE INNER PACKAGE, WHICH QUESTIONED PRODUCT STERILITY.
Patient problems: No Information
MAUDE report 7709822 ↗InjuryMay 17, 2017Improper or Incorrect Procedure or Method
DURING AN EMERGENT TRAUMA SITUATION, THE NURSING STAFF INJECTED THE WATER FROM THE SYRINGE INTO THE SUCTION PORT OF THE EXPRESS DRAIN AS THEY USUALLY DID WITH THE OASIS DRAINS. WHEN THE WATER CHAMBER DID NOT FILL THE NURSES THOUGHT THERE WAS A MALFUNCTION AND THE DRAINS WERE THROWN AWAY AND ANOTHER DRAIN USED. THE FACILITY WAS NEW TO THE EXPRESS DRAINS AND THE NURSING STAFF WAS NOT EDUCATED PRIOR TO USE.
Patient problems: No Information
MAUDE report 6574432 ↗
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- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- EXPRESS 16400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall110 reports
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OASIS 3612-100Atrium Medical Corporation · Bottle, Collection, Vacuum1 recall18 reports
- Medline DYNDSCL1500Medline Industries, Inc. · BOTTLE, COLLECTION, VACUUM1 recall13 reports
- PNEUMOSTAT 16100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 deaths12 reports
- OCEAN 2002-300Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.