Datascope recalls BEQ-T 9410 Lurie Chldns Small 1/4 Custom Tubing Kit (Catalog No. 709000430) due to potential air entry causing blood flow drops in ECMO circuits.
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Datascope is recalling its BEQ-T 9410 Lurie Chldns Small 1/4 Custom Tubing Kit because seal separation might let air into the device, reducing blood flow in ECMO circuits. This could lead to serious complications for patients using extracorporeal membrane oxygenation.
The tubing kit's seal may separate, allowing air to enter the device housing. This can collapse the balloon inside, increasing resistance in the venous line and reducing blood flow through the ECMO circuit. Reduced blood flow may cause serious complications for patients on life support.
Patients using ECMO systems with this specific tubing kit are most at risk. Healthcare providers who have purchased or use the recalled kit should check their equipment.
Check for the product name 'BEQ-T 9410 Lurie Chldns Small 1/4 Custom Tubing Kit' with catalog number 709000430. The kit was sold with lot number 3000060035.
Verify if your tubing kit has the catalog number 709000430 and lot number 3000060035.
Yes, the seal separation could allow air into the device, potentially reducing blood flow in ECMO circuits and causing serious complications.
Check if your kit matches the catalog number 709000430 and lot number 3000060035. If it does, contact Datascope for guidance.
Reduced blood flow in the ECMO circuit could lead to serious complications for patients on life support who use this tubing kit.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1706-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1706-2018 from Datascope. 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.