Maquet Medical Systems recalls BO-RF-32-USA RotaFlow pumps with SOFTLINE coating due to potential sterile barrier compromise. Breach could cause infection or sepsis in patients during extracorporeal circulation.
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
Take action
Contact the company
📍Recalling firmMaquet Medical Systems USA45 Barbour Pond Dr · Wayne, NJ 07470-2094
“Maquet RotaFlow Centrifugal Pump Recall: Sterile Barrier Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56397-maquet-rotaflow-centrifugal-pump-recall-sterile-barrier-risk. Based on FDA recall #Z-0978-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0978-2024%22&limit=1).
Maquet Medical Systems USA is recalling the BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating due to potential sterile barrier breaches that could expose patients to pathogens. The Food and Drug Administration announced the voluntary Class II recall on Jan. 8, 2024.
How to tell if you have it
Brand: Maquet Medical Systems
Product: BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating
Nonconformities at the seal could compromise the sterile barrier for affected products. A breach of the sterile barrier could expose patients to pathogenic agents, resulting in potential harms including inflammation, infection, or sepsis.
Context
GovInfoNow's records show Maquet Medical Systems USA has 14 other recalls on record since July 14, 2021. Recent brand recalls include a Jan. 16, 2024 recall of the Maquet BEQ-HLS 7050 for compromised sterile barrier risk and an April 15, 2024 recall of the Maquet Cardiohelp-i System for excessive patient leakage current risk. Other recent recalls of similar products include Medtronic DLP Retrograde Cannula Recall (April 21, 2026), Medtronic GUNDRY Cannula Recall (April 21, 2026), and Medtronic DLP Cannula Recall (April 21, 2026).
How to tell if you have this one
Check for the product code 701047553 on the pump. The pump was sold with specific lot numbers: 3000283239, 3000330438, 3000334430, 3000344495, and 3000351245.
Brand
Maquet Medical Systems
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR, PA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.
Recall number
Product, codes & lots
Z-0977-2024
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.; UDI-DI 4037691530864 Lots 3000286570 and 3000325568 ***Lots added 3/21/24*** 3000341070; 3000355577; 3000358977
Z-0978-2024
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.; UDI-DI 4037691650326 Lots 3000283239 and 3000330438 ***Lots added 3/21/24*** 3000334430; 3000344495; 3000351245
Based on the official FDA remedy
What to do — step by step
Check Pump Seal
Inspect the pump for any visible damage to the seal area that might indicate compromised sterility.
Contact Manufacturer
Reach out to Maquet Medical Systems for specific guidance on whether your pump is affected and next steps.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR, PA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Illinois, Maryland, Missouri, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0978-2024 (January 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0978-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.