Data / Medical devices / United States / Atrium Medical Corporation
Atrium Medical Corporation: FDA-registered device maker in Merrimack, NH, United States, 8 510(k) clearances and 1 PMA approval
Atrium Medical Corporation is registered with the FDA (registration 3011175548) in Merrimack, NH, United States. It lists 9 device types. The FDA files 8 510(k) clearances and 1 PMA approval under its listings, the newest dated March 28, 2024. 32 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3011175548
- Address
- 40 Continental Blvd, Merrimack, NH, United States, 03054
- Owner or operator
- ATRIUM MEDICAL CORPORATION (1219977)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- February 10, 1993
- Registered through
- 2027
- Brand names listed
- Advanta V12 Covered Stent System, Advanta VXT Graft, Advanta VXT Vascular Graft, Atrium Express Chest Drain Single Collection Dry Suction Dry Seal, Atrium Express Mini 500 Chest Drain Single Collection Dry Seal, Atrium Oasis Chest Drain Infant/Pediatric Collection Dry Suction Water Seal, Atrium Oasis Dry Suction Water Seal Chest Drain, Chest Drain Accessories (Connectors, Suction Bulbs, Suction Connectors and Tube Pack) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Specification developer | accessdata.fda.gov |
| Apparatus, Autotransfusion | CAC | 2 | Manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Cholangiography | GBZ | 1 | Specification developer | accessdata.fda.gov |
| Iliac Covered Stent, Arterial | PRL | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Specification developer | accessdata.fda.gov |
| Prosthesis, Tracheal, Expandable | JCT | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | DYF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 28, 2024 | K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | DSY | Substantially Equivalent | Atrium Medical Corporation | accessdata.fda.gov |
| September 3, 2021 | K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain | CAC | Substantially Equivalent | Atrium Medical Corporation | accessdata.fda.gov |
| August 14, 2007 | K071923 | PTFE FLIXENE GRADUATED WALL GRAFT | DSY | Substantially Equivalent | Atrium Medical Corp. | accessdata.fda.gov |
| March 30, 2006 | K060124 | ATRIUM FLIXENE GRAFT | DSY | Substantially Equivalent | Atrium Medical Corp. | accessdata.fda.gov |
| May 6, 2005 | K050814 | ATRIUM ICAST COVERED STENT | JCT | Substantially Equivalent | Atrium Medical Corp. | accessdata.fda.gov |
| October 1, 1999 | K992960 | ADVANTA GRAFT (>6MM) | DSY | Substantially Equivalent | Atrium Medical Corp. | accessdata.fda.gov |
| October 1, 1999 | K992958 | ADVANTA GRAFT (<6MM) | DYF | Substantially Equivalent | Atrium Medical Corp. | accessdata.fda.gov |
| October 4, 1983 | K831931 | ATRIUM THORACIC CATHETER | GBZ | Substantially Equivalent | Atrium Medical Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 22, 2023 | P120003 | iCast Covered Stent System | PRL | 11 | May 13, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 7, 2026 | 99680 | Class II | Ongoing | 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) | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | accessdata.fda.gov |
| September 9, 2024 | 95329 | Class II | Ongoing | iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 | There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. | accessdata.fda.gov |
| May 3, 2024 | 94614 | Class II | Ongoing | ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | accessdata.fda.gov |
| November 1, 2023 | 93553 | Class II | Ongoing | Atrium Oasis Drain Single W / AC, Part No. 3600-100 | A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025. | accessdata.fda.gov |
| September 29, 2023 | 93408 | Class II | Ongoing | Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date. | accessdata.fda.gov |
| September 21, 2023 | 93195 | Class II | Ongoing | 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 st | Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. | accessdata.fda.gov |
| September 18, 2023 | 93149 | Class II | Ongoing | 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, OCE | 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 | accessdata.fda.gov |
| September 5, 2023 | 93343 | Class II | Ongoing | Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION. | Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation. | accessdata.fda.gov |
| March 1, 2023 | 91718 | Class II | Ongoing | Atrium Pneumostat Chest Drain Valve, Part Number 16100 | 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. | accessdata.fda.gov |
| October 18, 2022 | 91043 | Class II | Ongoing | Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000 | Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients. | accessdata.fda.gov |
| April 21, 2022 | 90295 | Class II | Ongoing | 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 | Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date | accessdata.fda.gov |
| March 3, 2022 | 89852 | Class I | Ongoing | 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 8534 | Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associ | accessdata.fda.gov |
| October 22, 2021 | 88923 | Class II | Ongoing | 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 | Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient | accessdata.fda.gov |
| August 26, 2021 | 88446 | Class II | Ongoing | Atrium Pneumostat Chest Drain Valve, Part Number 16100 | The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died. | accessdata.fda.gov |
| August 25, 2021 | 88606 | Class II | Terminated | 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. | The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling. | accessdata.fda.gov |
| October 12, 2018 | 81524 | Class II | Terminated | Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 | This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is | accessdata.fda.gov |
| November 22, 2017 | 79293 | Class II | Terminated | 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 | An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298. | accessdata.fda.gov |
| May 25, 2017 | 77342 | Class II | Terminated | 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 (Markete | Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). The complaint device physica | accessdata.fda.gov |
| January 20, 2017 | 76138 | Class II | Terminated | Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008 | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) | accessdata.fda.gov |
| December 23, 2016 | 75707 | Class II | Terminated | 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 | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. | accessdata.fda.gov |
| November 29, 2016 | 75599 | Class II | Terminated | 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 | Outer Packaging is not sterile | accessdata.fda.gov |
| October 26, 2016 | 75347 | Class II | Terminated | 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. | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | accessdata.fda.gov |
| June 19, 2015 | 71510 | Class II | Terminated | Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236 | Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter | accessdata.fda.gov |
| May 7, 2015 | 71023 | Class II | Terminated | Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000 | Chest drains have a missing o-ring | accessdata.fda.gov |
| April 28, 2014 | 68398 | Class II | Terminated | Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus. | Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error. | accessdata.fda.gov |
| November 19, 2013 | 66788 | Class II | Terminated | 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. | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | accessdata.fda.gov |
| July 19, 2013 | 65698 | Class II | Terminated | C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies. | Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions | accessdata.fda.gov |
| July 16, 2013 | 65678 | Class II | Terminated | PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters. | Individual component's IFUs are not included with the kit. | accessdata.fda.gov |
| July 12, 2013 | 65697 | Class II | Terminated | Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field | accessdata.fda.gov |
| August 10, 2010 | 56536 | Not yet classified | Terminated | HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124 | Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters. | accessdata.fda.gov |
| May 12, 2008 | 48124 | Not yet classified | Terminated | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate | accessdata.fda.gov |
| November 8, 2006 | 36925 | Not yet classified | Terminated | Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N | Chest drainage tubing incorrectly assembled and may disconnect from patient during use | accessdata.fda.gov |
Compare with other makers
- All makers of Bottle, Collection, Vacuum
- All makers of Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- All makers of Iliac Covered Stent, Arterial
- All makers of Catheter, Cholangiography
- All makers of Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
- All makers of Apparatus, Autotransfusion
Updated September 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.