Fenwal CATSmart Vacuum Unit Recall: Failure Message During Use
Fenwal recalls CATSmart Vacuum Units with serial numbers starting 5VTA0180-7VTA0957 due to potential failure displaying 'Failure vacuum unit' message during use.
Use caution until it’s fixed
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
Contact the company
What happened, in plain English
Fenwal is recalling certain CATSmart Vacuum Units that may stop working and show a 'Failure vacuum unit' message during use. This could lead to interruptions in blood processing for medical procedures. Read more at govinfonow.com/recall/69019-fenwal-catsmart-vacuum-unit-recall-failure-message-during-use.
Source Summary by GovInfoNow · govinfonow.com/recall/69019-fenwal-catsmart-vacuum-unit-recall-failure-message-during-use · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1059-2019
Cite this page
“Fenwal CATSmart Vacuum Unit Recall: Failure Message During Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69019-fenwal-catsmart-vacuum-unit-recall-failure-message-during-use. Based on FDA recall #Z-1059-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1059-2019%22&limit=1).
Why it’s dangerous
The vacuum unit may malfunction during blood processing, causing it to display a failure message. This could interrupt the blood processing cycle and potentially lead to incomplete blood collection or reinfusion.
Who’s affected
Patients using Fresenius CATSmart (Continuous Autotransfusion System) for blood processing after surgery are most at risk. The affected units have specific serial numbers listed in the recall.
How to tell if you have this one
Check the serial number on the vacuum unit. Affected units have serial numbers starting with 5VTA0180 through 7VTA0957 as listed in the recall notice.
- Brand
Fenwal- Category
Medical device
What to do — step by step
Check Vacuum Unit Serial Number
Look for the serial number on the vacuum unit to confirm if it is in the affected range (5VTA0180 to 7VTA0957).
Contact Manufacturer for Details
If the unit is affected, contact Fenwal directly for further instructions on how to address the issue.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 23 states.
FDA distribution: “US Nationwide Distribution to states of: AZ, CA, FL, HI, ID, IL, IN, MD, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OK, OR, PA, TN, TX, VA and PR; and Internationally to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Hawaii, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1059-2019 (February 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1059-2019 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.