Maquet recalls BEQ-T 3501 LVAD pumps with batch 3000074094 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 a specific model of LVAD pump (BEQ-T 3501) with batch number 3000074094 because sterilization might not ensure sterility. This could lead to infections if the device is used without proper sterility.
During sterilization, the closed stopcock configuration can trap humidity and ethylene oxide gas, preventing proper sterility assurance. This might lead to contamination of the device if not handled correctly.
Patients using the BEQ-T 3501 LVAD pump with batch number 3000074094 are most at risk. Healthcare providers who handle these devices during sterilization may also be affected.
Check for the batch number 3000074094 on the BEQ-T 3501 LVAD pump. The product is sold under Maquet Getinge with material code 701068008R01.
Look for batch number 3000074094 on the BEQ-T 3501 LVAD pump.
The recall addresses potential sterility issues during sterilization, which could lead to infections if the device is not properly sterilized. However, the risk is low if handled correctly.
Check for batch number 3000074094 on the BEQ-T 3501 LVAD pump with material code 701068008R01.
The recall does not specify a remedy, so contact Maquet directly for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1670-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1670-2019 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.
