Facility

Atrium Medical Corporation

29 recall(s) on record — most severe on record: Class I.

Key facts

29recalls · worst Class I

5inspections · worst OAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011175548
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	40 Continental Blvd Merrimack, NH, US 03054
Registration status	Active · expires 2026
Parent company	ATRIUM MEDICAL CORPORATION (owner-operator 1219977)
Brand names	Thoracic catheters PVC and Firm

Activity by year

Recalls (29)
Inspections (5)

Devices registered here (1)

Catheter, Cholangiography
Product code GBZ (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4200

Recalls & enforcement

20261 record

Class IIOngoing2026-08-07
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

20242 records

Class IIOngoing2024-09-09
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Class IIOngoing2024-05-03
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

20236 records

Class IIOngoing2023-11-01
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…
Class IIOngoing2023-09-29
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Class IIOngoing2023-09-21
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Class IIOngoing2023-09-18
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
Class IIOngoing2023-09-05
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.
Class IIOngoing2023-03-01
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 th…

20223 records

Class IIOngoing2022-10-18
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
Class IIOngoing2022-04-21
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…
Class IOngoing2022-03-03
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 pa…

20213 records

Class IIOngoing2021-10-22
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
Class IIOngoing2021-08-26
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.
Class IITerminated2021-08-25
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.

20181 record

Class IITerminated2018-10-12
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 c…

20173 records

Class IITerminated2017-11-22
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.
Class IITerminated2017-05-25
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 38…
Class IITerminated2017-01-20
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)

20163 records

Class IITerminated2016-12-23
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Class IITerminated2016-11-29
Outer Packaging is not sterile
Class IITerminated2016-10-26
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

20152 records

Class IITerminated2015-06-19
Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
Class IITerminated2015-05-07
Chest drains have a missing o-ring

20141 record

Class IITerminated2014-04-28
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.

20134 records

Class IITerminated2013-11-19
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Class IITerminated2013-07-19
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
Class IITerminated2013-07-16
Individual component's IFUs are not included with the kit.
Class IITerminated2013-07-12
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field

FDA inspections (5)

VAI2024-11-26
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-09-06
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
OAI2020-02-10
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
OAI2016-07-13
Official Action Indicated · Compliance: Devices
NAI2016-01-08
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by ATRIUM MEDICAL CORPORATION

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Atrium Medical Corporation (FEI 3011175548) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011175548-atrium-medical-corporation/

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