Lower risk Medical device recall · FDA · Published August 8, 2018

Medtronic Perfusion Systems Extra Corporeal Circuit Recall: Sterilization Failure

Medtronic Perfusion Systems recalls extra corporeal circuits with bio-active surfaces that failed sterilization tests. Affected units may pose infection risks.

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

🇺🇸 FDA recall #Z-2495-2020Medical device Medtr: a short, human brand name for headings (e.g. "Trsmima") ›

Lower-risk recall

Affected products failed a sterilization test.

Take action

Contact the company

Recalling firmMedtronic Perfusion Systems7611 Northland Dr N · Brooklyn Park, MN 55428-1088

✎ GovInfoNow plain-language explainer

Medtronic Perfusion Systems is recalling extra corporeal circuits with bio-active surfaces that failed sterilization tests. This could lead to infection risks if the device is used. Read more at govinfonow.com/recall/70169-medtronic-perfusion-systems-extra-corporeal-circuit-recall-sterilization-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/70169-medtronic-perfusion-systems-extra-corporeal-circuit-recall-sterilization-failure · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2495-2020

Cite this page

“Medtronic Perfusion Systems Extra Corporeal Circuit Recall: Sterilization Failure.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70169-medtronic-perfusion-systems-extra-corporeal-circuit-recall-sterilization-failure. Based on FDA recall #Z-2495-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2495-2020%22&limit=1).

The FDA announced on August 8, 2018, that Medtronic Perfusion Systems is recalling one lot of extra corporeal circuits with bio-active surfaces due to sterilization failures. The agency classified the recall as Class II.

How to tell if you have it

Brand: Medtronic
Product: Extra corporeal circuit with bio-active surface
Lot#: 215729283
Quantity: 10 units

The hazard

According to the FDA, the affected products failed a sterilization test.

Context

GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since June 22, 2017. Other recent recalls of similar products include Argon Medical Devices: Transvenous Pacing Electrode Tray Recall Due to Sterility Risk (June 1, 2026) and Medline Convenience Kits Recalls regarding calibration issues affecting sterility (January 7, 2026).

How to tell if you have this one

Check for the lot number 215729283 on the circuit packaging. The product is an extra corporeal circuit with a bio-active surface.

Brand
Medtr: a short, human brand name for headings (e.g. "Trsmima")
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot number 215729283 on the circuit packaging.

Where it went and when

Where it was distributed

Distributed in California and Michigan.

FDA distribution: “Domestic Distribution only to CA and MI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Michigan.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Aug 8, 2018Firm started the recall
Jul 4, 2020FDA classified it Class II
Jul 15, 2020Published in FDA’s Enforcement Report
Oct 6, 2020FDA terminated the recall

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

Similar recalls

Latest medical device recalls

Keep exploring

More Medtr: a short, human brand name for headings (e.g. "Trsmima") recalls

Link to this recall

<a href="https://govinfonow.com/recall/70169-medtronic-perfusion-systems-extra-corporeal-circuit-recall-sterilization-failure">Medtronic Perfusion Systems Extra Corporeal Circuit Recall: Sterilization Failure (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-2495-2020 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2495-2020 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.