Atrium Medical Corporation: FDA recalls

FDA enforcement reports name Atrium Medical Corporation as the recalling firm in 29 events. The events have 153 product records. The recalls started from 2013 to 2026. All the events are device recalls.

See the 29 events

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.

Enforcement events

29 events, newest first.

FDA enforcement events of Atrium Medical Corporation
Initiated	Product (first record)	Type	Class	Records	Status
7 Aug 2026	Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);	Device	Class II	3	Ongoing
9 Sep 2024	iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616	Device	Class II	1	Ongoing
3 May 2024	ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft	Device	Class II	68	Ongoing
1 Nov 2023	Atrium Oasis Drain Single W / AC, Part No. 3600-100	Device	Class II	1	Ongoing
29 Sep 2023	Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.	Device	Class II	1	Ongoing
21 Sep 2023	Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361	Device	Class II	1	Ongoing
18 Sep 2023	Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000…	Device	Class II	3	Ongoing
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	Ongoing
1 Mar 2023	Atrium Pneumostat Chest Drain Valve, Part Number 16100	Device	Class II	2	Ongoing
18 Oct 2022	Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000	Device	Class II	1	Ongoing
21 Apr 2022	Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028	Device	Class II	1	Ongoing
3 Mar 2022	Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360 85361 85364 85365 85388 85389 85390 85391…	Device	Class I	2	Ongoing
22 Oct 2021	The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical…	Device	Class II	1	Ongoing
26 Aug 2021	Atrium Pneumostat Chest Drain Valve, Part Number 16100	Device	Class II	1	Ongoing
25 Aug 2021	Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.	Device	Class II	1	Terminated
12 Oct 2018	Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128	Device	Class II	1	Terminated
22 Nov 2017	ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.	Device	Class II	1	Terminated
25 May 2017	Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of tracheobronchial…	Device	Class II	1	Terminated
20 Jan 2017	Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008	Device	Class II	2	Terminated
23 Dec 2016	Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the…	Device	Class II	7	Terminated
29 Nov 2016	Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with in-line connector and suction control…	Device	Class II	10	Terminated
26 Oct 2016	Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.	Device	Class II	8	Terminated
19 Jun 2015	Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236	Device	Class II	1	Terminated
7 May 2015	Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000	Device	Class II	4	Terminated
28 Apr 2014	Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.	Device	Class II	1	Terminated
19 Nov 2013	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.	Device	Class II	9	Terminated
19 Jul 2013	C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.	Device	Class II	4	Terminated
16 Jul 2013	PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.	Device	Class II	1	Terminated
12 Jul 2013	Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.	Device	Class II	14	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

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

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

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Type and class

Atrium Medical Corporation: events for each product type
Type		Events
Device		29

Atrium Medical Corporation: events in each class
Class		Events
Class II		28
Class I		1

Share of the events of the firm in Class I: 3%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 14

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.

Events by year

FDA enforcement events of Atrium Medical Corporation, by the year that the recall started. The largest year is 2023, with 6 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Atrium Medical Corporation: FDA recalls. https://recallregister.com/firm/atrium-medical-corporation/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: NH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Atrium Medical Corporation have?: Class II: 28 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Atrium Medical Corporation?: FDA event 99680, which the firm started on 7 Aug 2026. The first product in the record is: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
How many FDA recalls of Atrium Medical Corporation have the status Ongoing?: 14 events have the status Ongoing in the openFDA file. openFDA says 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.