Maquet recalls specific Getinge-BEQ-T 3501 LVAD models with batch numbers 3000042629 and 3000057758 due to potential sterility issues during sterilization. Affected units may not meet sterility standards if improperly configured.
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 3501 LVAD models with specific batch numbers because their tubing sets might not maintain sterility during sterilization. This could lead to infections if the device is used without proper sterility.
During sterilization, the closed stopcock configuration in these tubing sets may block humidity and ethylene oxide gas from flowing into the fluid path. This prevents the sterility assurance level from being maintained, increasing infection risk.
Healthcare professionals using the Maquet Getinge-BEQ-T 3501 LVAD models with batch numbers 3000042629 and 3000057758 are most at risk. Patients receiving these devices could face infection if the sterility assurance is compromised.
Check for batch numbers 3000042629 or 3000057758 on the Maquet Getinge-BEQ-T 3501 LVAD model with 3/8" material code 701068008.
Look for batch numbers 3000042629 or 3000057758 on the device.
The recall includes batch numbers 3000042629 and 3000057758.
The tubing sets may not maintain sterility during sterilization, potentially leading to infections if the device is used without proper sterility assurance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1590-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1590-2019 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.
