Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0129-2013.
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0129-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0129-2013.
Terumo Cardiovascular Systems Corporation
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Terumo Cardiovascular Systems Corporation Recall FAQ
Terumo Cardiovascular Systems Corporation is the subject of a medical devices safety report: Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for.... The notice was published on September 25, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 312 units are potentially affected.