Device recall: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors…

Class II FDA enforcement event 66788. Recall start date: 19 Nov 2013. Status in the FDA record: Terminated. Termination date: 11 Jun 2015.

Reason for recall, in the words of FDA

Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

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 19 Nov 2013. The firm address in the FDA record is in Hudson, NH. FDA put the recall in Class II. FDA event 66788 has 9 product records. The first FDA enforcement report date is 22 Jan 2014. The record gives the status Terminated, with the termination date 11 Jun 2015.

FDA enforcement report The 9 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-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

Recalling firm

Atrium Medical Corporation, Hudson, NH.

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

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

Products

9 product records in the event.

FDA event 66788: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0735-2014	Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.	10,448 units	Class II	Terminated	22 Jan 2014
Z-0736-2014	Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.	624 units	Class II	Terminated	22 Jan 2014
Z-0737-2014	Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.	6,684 units	Class II	Terminated	22 Jan 2014
Z-0738-2014	Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum.	361 units	Class II	Terminated	22 Jan 2014
Z-0739-2014	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 chest cavity or mediastinum.	1,002 units	Class II	Terminated	22 Jan 2014
Z-0740-2014	Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.	42,699 units	Class II	Terminated	22 Jan 2014
Z-0741-2014	Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.	954 units	Class II	Terminated	22 Jan 2014
Z-0742-2014	Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.	7,274 units	Class II	Terminated	22 Jan 2014
Z-0743-2014	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 chest cavity or mediastinum.	1,944 units	Class II	Terminated	22 Jan 2014

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 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 9Median 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
1 Mar 2023	Atrium Pneumostat Chest Drain Valve, Part Number 16100	Device	Class II	2
18 Oct 2022	Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000	Device	Class II	1

Atrium Medical Corporation: all 29 events

Official channels

FDA enforcement report Z-0735-2014The 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 66788. https://recallregister.com/fda/ii/66788/. 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-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
What quantity of product is in FDA event 66788?: The event has 9 product records. The first record gives this quantity: 10,448 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.