Maquet recalls specific Getinge-BEQ-T 3502 LVAD models due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels if used incorrectly.
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 devices because their tubing design could lead to sterility problems during sterilization. This means the medical device might not stay sterile after processing, which is critical for patient safety.
The tubing's closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level of the device, potentially leading to infections.
Patients using the recalled LVAD devices for heart failure treatment. Healthcare providers who handle these devices during sterilization processes are at risk.
Check for the model number Getinge-BEQ-T 3502 LVAD with material code 701068168R01. Affected units have batch numbers 3000074095 or 3000082174.
Identify the model number on the device label to confirm if it matches Getinge-BEQ-T 3502 LVAD with material code 701068168R01.
Reach out to Maquet Cardiovascular for specific guidance on handling or replacing the device if it is affected.
The tubing design may prevent proper humidity and gas flow during sterilization, which could compromise the device's sterility assurance level.
Batch numbers 3000074095 and 3000082174 are affected.
The recall does not require immediate discontinuation; affected devices should be checked and contacted with the manufacturer 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-1671-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1671-2019 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.
