Datascope recalls BEQ-T 25501 3/8" Better Bladder Pack for potential air entry into ECMO circuits, risking blood flow drops. Affected units have Catalog No. 709000370.
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 25501 3/8" Better Bladder Pack due to a risk of air entering the ECMO circuit, which could reduce blood flow. This affects custom tubing kits with Catalog No. 709000370.
The seal between the bladder pack and its housing can separate, allowing air to enter the ECMO circuit. This may increase resistance in the venous line and cause a drop in blood flow, potentially harming patients.
Patients using ECMO (extracorporeal membrane oxygenation) systems with this specific bladder pack are most at risk. Healthcare providers who use the product in medical settings may also be affected.
Check for the Catalog No. 709000370 on the product label. The product is sold as part of custom tubing kits with the BEQ-T 25501 3/8" Better Bladder Pack.
Look for Catalog No. 709000370 on the Better Bladder Pack or Custom Tubing Kit.
The recall states that seal separation may occur, so it's not safe to use without checking for the issue.
The official recall record does not specify a remedy, so contact Datascope Corporation for guidance.
Check for Catalog No. 709000370 on the Better Bladder Pack or Custom 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-1723-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1723-2018 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.