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.
Maquet Medical Systems is recalling certain RotaFlow centrifugal pumps that may have seal issues compromising the sterile barrier. This could expose patients to infections or sepsis during heart-lung bypass procedures.
The pump's seal could fail, breaking the sterile barrier that protects patients during heart-lung bypass surgery. This breach might allow harmful bacteria to enter the bloodstream, causing infections or sepsis.
Patients undergoing extracorporeal cardiovascular or cardiopulmonary bypass procedures using the recalled pumps are most at risk. Healthcare facilities that use these pumps for such procedures may also be affected.
Check for the product code 701047553 on the pump. The pump was sold with specific lot numbers: 3000283239, 3000330438, 3000334430, 3000344495, and 3000351245.
Inspect the pump for any visible damage to the seal area that might indicate compromised sterility.
Reach out to Maquet Medical Systems for specific guidance on whether your pump is affected and next steps.
The product code is 701047553.
Affected lot numbers include 3000283239, 3000330438, 3000334430, 3000344495, and 3000351245.
A seal failure could break the sterile barrier during heart-lung bypass procedures, potentially exposing patients to infections or sepsis.
We’ve drafted a message you can send Maquet Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0978-2024 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-0978-2024 from Maquet Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
