Datascope recalls BEQ-TOP 24500 Adult ECC Custom Tubing Kits with catalog number 701050253 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 some BEQ-TOP 24500 Adult ECC Custom Tubing Kits because seal separation might let air into the device, reducing blood flow in ECMO circuits. This could cause serious complications for patients using extracorporeal membrane oxygenation.
The tubing kit's seal may separate from the housing, allowing air to enter the device. This can increase resistance in the venous line and reduce blood flow through the ECMO circuit, potentially causing serious complications.
Patients using ECMO therapy with this specific tubing kit are at risk. Healthcare providers who have the recalled model should check their inventory.
Check for catalog number 701050253 on the tubing kit. The recalled units were sold with lot numbers 3000055326 or 3000064943.
Identify the catalog number and lot numbers to confirm if your tubing kit is recalled.
The recall indicates potential air entry risk, so it is not safe to use without checking if it's recalled.
The official notice does not specify a remedy, so contact Datascope Corporation for guidance.
Look for catalog number 701050253 and lot numbers 3000055326 or 3000064943.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1726-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1726-2018 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.