Maquet ROTAFLOW Drive Recall: Loose Plug May Cause Flow Fluctuations
Maquet recalls ROTAFLOW Drive model 701022161 due to loose ODU plug causing flow fluctuations. Affected units have specific serial numbers and UDI.
Lower-risk recall
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Contact the company
What happened, in plain English
Maquet is recalling a specific ROTAFLOW Drive model because a loose plug can cause flow measurements to fluctuate. This could lead to inaccurate readings during medical procedures. Read more at govinfonow.com/recall/66404-maquet-rotaflow-drive-recall-loose-plug-may-cause-flow-fluctuations.
Source Summary by GovInfoNow · govinfonow.com/recall/66404-maquet-rotaflow-drive-recall-loose-plug-may-cause-flow-fluctuations · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0678-2020
Cite this page
“Maquet ROTAFLOW Drive Recall: Loose Plug May Cause Flow Fluctuations.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66404-maquet-rotaflow-drive-recall-loose-plug-may-cause-flow-fluctuations. Based on FDA recall #Z-0678-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0678-2020%22&limit=1).
Why it’s dangerous
A loose ODU plug or coaxial cable connection can cause the flow values displayed on the console to fluctuate. This may lead to inaccurate readings during critical medical procedures.
Who’s affected
Healthcare professionals using the ROTAFLOW Drive system for medical procedures are most likely affected. The recall targets specific model units with known serial numbers.
How to tell if you have this one
Check for the model number 701022161 on the device. Affected units have specific serial numbers listed in the recall notice and a unique UDI code.
- Brand
Maquet- Category
Medical device
What to do — step by step
Check Device Model
Identify the model number on the device, which should be 701022161.
Verify Serial Number
Compare your device's serial number to the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in 7 states.
FDA distribution: “The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Maine, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia.
Recall timeline
FDA terminated this recall 10 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.
Questions people ask
Is this device dangerous?
The recall is for potential flow fluctuations, which could affect medical readings but does not pose a direct safety risk to users.
What should I do if I have this device?
The recall does not require immediate action; you can check the model and serial number to confirm if your device is affected.
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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-0678-2020 (December 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0678-2020 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.