Datascope recalls BEQ-T 25502 Better Bladder kits with potential air entry causing ECMO blood flow drops. Affected units sold with Catalog No. 709000434.
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 has recalled certain Better Bladder kits for ECMO use because air could enter the device and reduce blood flow in life-support systems. This could cause serious complications for patients on ECMO treatment.
The Better Bladder device can develop seal separation from its housing, allowing air to enter the system. This air entry increases resistance in the venous line, which may drop blood flow through the ECMO circuit. Reduced blood flow can cause serious complications for patients on ECMO.
Patients using ECMO life support systems with this specific Better Bladder kit are most at risk. Healthcare providers who use the kit for custom tubing setups may also be affected.
Check for the product name 'BEQ-T 25502 1/4 Better Bladder' with Catalog No. 709000434. The kit was sold with Lot 3000062029.
If the Better Bladder shows seal separation from its housing, air may have entered the system.
No, this recall applies specifically to ECMO life support systems. The device is not intended for general medical use.
The recall record does not specify a remedy, so contact Datascope Corporation directly for guidance.
Look for Catalog No. 709000434 with the BEQ-T 25502 1/4 Better Bladder model and Lot 3000062029.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1722-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1722-2018 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.
