Use caution Medical device recall · FDA · Published October 12, 2018

Atrium 28Fr PVC Thoracic Catheter Right Angle Recall: Seal Defect Risk

Atrium Medical recalls specific thoracic catheters due to seal defects in sterile pouches that could cause contamination. Affected units may pose serious infection risks if not properly sealed.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0560-2019Medical device Atrium Medical ›

Use caution until it’s fixed

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 used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved and the patient s risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.

Take action

Contact the company

Recalling firmAtrium Medical Corporation40 Continental Blvd · Merrimack, NH 03054-4332

✎ GovInfoNow plain-language explainer

Atrium Medical is recalling a specific type of thoracic catheter because some sterile packaging has a seal defect that could lead to contamination. If the packaging isn't properly sealed, the catheter could become contaminated, which might cause serious infections in patients. Read more at govinfonow.com/recall/69637-atrium-28fr-pvc-thoracic-catheter-right-angle-recall-seal-defect.

Source Summary by GovInfoNow · govinfonow.com/recall/69637-atrium-28fr-pvc-thoracic-catheter-right-angle-recall-seal-defect · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0560-2019

Cite this page

“Atrium 28Fr PVC Thoracic Catheter Right Angle Recall: Seal Defect Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69637-atrium-28fr-pvc-thoracic-catheter-right-angle-recall-seal-defect. Based on FDA recall #Z-0560-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0560-2019%22&limit=1).

The FDA announced on 2018-10-12 that Atrium Medical Corporation is recalling the Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE due to a seal defect in sterile barrier pouches. The agency stated the unsealed pouches could lead to product contamination and pose a serious hazard to patients.

How to tell if you have it

Brand: Atrium Medical
Product: Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE
Part No.: 8128
ME221275
Units: 2930

The hazard

The recall addresses a seal defect in certain sterile barrier pouches containing the device, which are un-sealed at the bottom. A sterility breach could potentially lead to product contamination, and if contaminated, the consequences for the patient could be severe because the device contacts critical anatomical structures. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.

Context

GovInfoNow's records show Atrium Medical Corporation has 16 other recalls on record since 2017-11-22. Other recent recalls include the Getinge Thoracic Catheter Recall (2026-08-07) and the Atrium Medical iCast Stent Recall (2024-09-09). Similar recent recalls of catheters include the Stryker BARD Dynamic Deca Steerable Catheter Recall, the Stryker BARD EP XT Decapolar Steerable Catheter Recall, and the Stryker Daig Livewire Steerable Catheter Recall, all dated 2026-04-10.

How to tell if you have this one

Check for the product name 'Atrium 28Fr PVC Thoracic Catheter Right Angle' with part number 8128. The affected units were sold with the model code ME221275.

Brand
Atrium Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Packaging Seal
Inspect the sterile pouch for an unsealed bottom; if present, the device is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.” 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 terminated this recall 19 months after the firm started it.

Oct 12, 2018Firm started the recall
Dec 6, 2018FDA classified it Class II
Dec 12, 2018Published in FDA’s Enforcement Report
May 12, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69637-atrium-28fr-pvc-thoracic-catheter-right-angle-recall-seal-defect">Atrium 28Fr PVC Thoracic Catheter Right Angle Recall: Seal Defect Risk (GovInfoNow)</a>

Where this comes from

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-0560-2019 (October 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0560-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.