Device recall: Atrium Pneumostat Chest Drain Valve, Part Number 16100

Class II FDA enforcement event 91718. Recall start date: 1 Mar 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Atrium Medical Corporation started this device recall on 1 Mar 2023. The firm address in the FDA record is in Merrimack, NH. FDA put the recall in Class II. FDA event 91718 has 2 product records. The first FDA enforcement report date is 5 Apr 2023. The record gives the status Ongoing.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia,…

Recalling firm

Atrium Medical Corporation, Merrimack, NH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 91718: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1302-2023	Atrium Pneumostat Chest Drain Valve, Part Number 16100	3554 cases of 10	Class II	Ongoing	5 Apr 2023
Z-1303-2023	Express Mini 500 Dry Seal Chest Drain, Part Number 16400	8184 cases of 6	Class II	Ongoing	5 Apr 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class II: 88%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 29

Other events of the firm

Other FDA enforcement events of Atrium Medical Corporation
Initiated	Product (first record)	Type	Class	Records
7 Aug 2026	Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR	Device	Class II	3
9 Sep 2024	iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616	Device	Class II	1
3 May 2024	ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft	Device	Class II	68
1 Nov 2023	Atrium Oasis Drain Single W / AC, Part No. 3600-100	Device	Class II	1
29 Sep 2023	Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.	Device	Class II	1
21 Sep 2023	Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of t	Device	Class II	1
18 Sep 2023	Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-	Device	Class II	3
5 Sep 2023	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION	Device	Class II	2
18 Oct 2022	Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000	Device	Class II	1
21 Apr 2022	Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavi	Device	Class II	1

Atrium Medical Corporation: all 29 events

Official channels

FDA enforcement report Z-1302-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 91718. https://recallregister.com/fda/ii/91718/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia,…
What quantity of product is in FDA event 91718?: The event has 2 product records. The first record gives this quantity: 3554 cases of 10
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 88% of the 917 device events that started in 2023 are in Class II.