Datascope recalls BEQ-TOP 25500 ECC 3/8 with Custom Tubing Kit (Catalog 701052461) due to potential air entry causing blood flow drops in ECMO circuits. Affected units have specific lot numbers.
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 25500 ECC 3/8 ECMO tubing kits because a seal issue might let air into the device, reducing blood flow in life-support systems. This could cause serious complications for patients using ECMO therapy.
The seal between the tubing and housing can separate, allowing air to enter the device. This may increase resistance in the venous line and reduce blood flow through the ECMO circuit, potentially causing serious complications for patients.
Patients using ECMO therapy with this specific tubing kit are most at risk. The recall affects units sold with Catalog Number 701052461 and Lot 3000065224.
Check for the Catalog Number 701052461 on the tubing kit. Affected units were sold with Lot 3000065224. The product name is BEQ-TOP 25500 ECC 3/8 with Custom Tubing Kit.
If you notice reduced blood flow in your ECMO circuit, stop using the device immediately.
The recall states that the seal separation could cause air entry and blood flow issues, so it is not safe to use without the remedy.
The recall record does not specify a remedy, so contact Datascope Corporation for guidance.
Look for Catalog Number 701052461 and Lot 3000065224 on the BEQ-TOP 25500 ECC 3/8 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-1724-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1724-2018 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.
