PNEUMOSTAT 16100Recalls & reported problems
Atrium Medical Corporation · PNEUMOSTAT CHEST DRAIN VALVE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 12
- Deaths reported
- 3
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00650862161007), received between May 18, 2017 and Dec 10, 2020 — classified as 3 deaths, 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K984496); 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.
Recalls naming this device
- Mar 1, 2023Open, Classified
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
Z-1302-2023 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Fluid/Blood Leak3
- Leak/Splash3
- Crack2
- Break1
- Detachment of Device or Device Component1
- Gas/Air Leak1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient4
- Death3
- Pneumothorax3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT WENT HOME WITH A PNEUMOSTAT AND CAME BACK TO HOSPITAL WITH A PNEUMOTHORAX.
Patient problems: Pneumothorax
MAUDE report 10988973 ↗DeathOct 3, 2020Adverse Event Without Identified Device or Use Problem
REPORT RECEIVED FROM THERAPEUTIC GOODS ADMINISTRATION (TGA): PRETERM BABY DELIVERED AFTER HOURS AT 0432AM IN OPERATING THEATRES BY CAESAREAN SECTION AT A (B)(6) HOSPITAL. THE BABY REQUIRED PROLONGED RESUSCITATION AND WAS INTUBATED AND VENTILATED WITH DIFFICULTY. A LEFT TENSION PNEUMOTHORAX DEVELOPED WHILE THE BABY WAS STILL IN OPERATING THEATRES, AND AFTER INITIAL NEEDLE DRAINAGE, AN INTERCOSTAL CATHETER WAS INSERTED AND CONNECTED TO A PNEUMOSTAT CHEST DRAIN VALVE. THE BABY WAS MOVED TO THE NEONATAL INTENSIVE CARE UNIT (NICU) AT 90 MINUTES OF AGE. AT FIRST X-RAY IN THE NICU (0626AM), THERE WAS STILL LEFT PNEUMOTHORAX PRESENT ALTHOUGH MUCH SMALLER, AND A RIGHT TENSION PNEUMOTHORAX HAD DEVELOPED, AS WELL AS SURGICAL EMPHYSEMA. A RIGHT INTERCOSTAL CATHETER WAS INSERTED AND ALSO CONNECTED TO A PNEUMOSTAT CHEST DRAIN VALVE. ON THE NEXT X-RAY AT 0655AM, THE RIGHT PNEUMOTHORAX WAS RELIEVED WITH RIGHT LUNG RE EXPANSION, HOWEVER THE LEFT PNEUMOTHORAX WAS NOW INCREASED IN SIZE. ON CXR AT 0748, THERE WAS AGAIN A RIGHT TENSION PNEUMOTHORAX, AS WELL AS ONGOING LEFT PNEUMOTHORAX. ON X-RAY AT 0757, THERE WAS BILATERAL TENSION PNEUMOTHORAX. THE PATIENT PASSED AWAY THE SAME MORNING.
Patient problems: Death
MAUDE report 10624472 ↗DeathOct 3, 2020Adverse Event Without Identified Device or Use Problem
DeathOct 3, 2020Labelling, Instructions for Use or Training Problem
MalfunctionAug 6, 2020Crack; Fluid/Blood Leak; Material Fragmentation
IT WAS REPORTED THAT THE PLASTIC OF THE SECRETION CHAMBER ON THE LUER PORT WAS LEAKING, SHOWING CRACKS AND BREAKING OFF WITHOUT THE USE OF FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10377238 ↗MalfunctionMar 2, 2020Leak/Splash
REPORT RECEIVED STATED THAT THE NURSE FOUND THAT A PNEUMOSTAT WAS LEAKING FROM THE WHITE CHAMBER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9777727 ↗InjurySep 26, 2019Gas/Air Leak
MalfunctionJul 24, 2019Break; Detachment of Device or Device Component
MalfunctionJul 3, 2019Fluid/Blood Leak
MalfunctionJul 2, 2019Fluid/Blood Leak
MalfunctionSep 10, 2018Crack; Leak/Splash
IT WAS REPORTED THE PATIENT HAD INTERCOSTAL TUBE DAMAGE FROM PNEUMOTHORAX. THE PNEUMOSTAT WAS CONNECTED TO THE EXISTING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). POST ATTACHMENT AN EXTERNAL AIR LEAK WAS NOTICED AND THE PNEUMOSTAT WAS DISCONNECTED. ON EXAMINATION A SMALL CRACK ON THE INLET PART WAS NOTICED.
Patient problems: Pneumothorax
MAUDE report 7862467 ↗MalfunctionMay 18, 2017Leak/Splash
THE PNEUMOSTAT DRAIN LEAKED THROUGH THE AIR LEAK MONITOR WHEN IN A POSITION OTHER THAN UPRIGHT. PATIENT DRAINING MORE THAN 30 ML PER DAY. PATIENT WAS SWITCHED TO AN EXPRESS MINI WITHOUT ANY ISSUE AND PATIENT DISCHARGED THE NEXT DAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6575471 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K984496. One submission often covers many models, so check the product and lot details in each record.
- Z-2592-2021 · Aug 26, 2021 · Open, ClassifiedAtrium Pneumostat Chest Drain Valve, Part Number 16100
- Z-1208-2017 · Dec 23, 2016 · TerminatedMaquet 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
Other BOTTLE, COLLECTION, VACUUM devices
- OASIS 3600-100Atrium Medical Corporation · Bottle, Collection, Vacuum3 recalls1 death175 reports
- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- EXPRESS 16400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall110 reports
- EXPRESS 4000-100NAtrium Medical Corporation · Bottle, Collection, Vacuum2 recalls30 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
- OCEAN 2002-300Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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