Maquet recalls specific Getinge-BEQ-T 3502 LVAD models with batch numbers 3000042630, 3000053054, 3000054960, 3000058830 due to potential sterility issues during sterilization.
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Maquet is recalling certain Getinge-BEQ-T 3502 LVAD pumps with specific batch numbers because their tubing design might not properly handle sterilization processes, risking infection. This is serious for patients using these devices.
During sterilization, the closed stopcock design in these pumps may block humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility of the pump components, increasing infection risk during medical use.
Patients using the recalled LVAD pumps with batch numbers 3000042630, 3000053054, 3000054960, or 3000058830 are most at risk. Healthcare providers using these pumps for extracorporeal circulation may also be affected.
Check the batch number on the pump's label: 3000042630, 3000053054, 3000054960, or 3000058830. The product is a Getinge-BEQ-T 3502 LVAD with 1/4" tubing material code 701068168.
Look for batch numbers 3000042630, 3000053054, 3000054960, or 3000058830 on the pump's label.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking infection.
Check the batch number on the pump's label. If it matches the recalled numbers, contact Maquet for guidance.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1591-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1591-2019 from Maquet. 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.
