UnratedMedical device recall · FDA · Published August 26, 2021
Atrium Pneumostat Chest Drain Valve Recall: Safety Update After Infant Death
Atrium Medical recalls specific chest drain valve models due to involvement in a preterm infant's death. Learn which units are affected and safety steps.
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.
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Contact the company
📍Recalling firmAtrium Medical Corporation40 Continental Blvd · Merrimack, NH 03054-4332
“Atrium Pneumostat Chest Drain Valve Recall: Safety Update After Infant Death.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61889-atrium-pneumostat-chest-drain-valve-recall-safety-update-after-infant. Based on FDA recall #Z-2592-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2592-2021%22&limit=1).
The FDA announced on Aug. 26, 2021, that Atrium Medical Corporation is recalling the Atrium Pneumostat Chest Drain Valve, Part Number 16100. The firm is revising labeling after the device was involved in the treatment of a preterm infant who later died.
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.
Context
GovInfoNow's records show Atrium Medical Corporation has 16 other recalls on record since Nov. 22, 2017. Other recent recalls of similar products include Getinge Thoracic Catheter Recall (Aug. 7, 2026), Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall (Nov. 6, 2025), and Boston Scientific FARADRIVE Steerable Sheath Recall (June 11, 2026).
How to tell if you have this one
Check for the part number 16100 on the valve. Affected units were sold with specific lot numbers listed in the recall notice.
Brand
Atrium Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Lot Number
Look for the lot numbers listed in the recall notice to determine if your valve is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide. Foreign distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2592-2021 (August 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2592-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.