Datascope recalls ECC Small Respiratory BEQ-TOP 5210 Custom Tubing Kit (Catalog No. 701055604) 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 ECC Small Respiratory BEQ-TOP 5210 Custom Tubing Kits because a seal issue might let air into the device, reducing blood flow in ECMO systems. This could lead to serious complications for patients using extracorporeal membrane oxygenation.
The seal between the device and housing can separate, allowing air to enter the system. This may increase resistance in the venous line and cause a drop in blood flow through the ECMO circuit, potentially leading to serious complications for patients.
Patients using extracorporeal membrane oxygenation (ECMO) systems with this specific tubing kit are most at risk. The recall applies to the ECC Small Respiratory BEQ-TOP 5210 Custom Tubing Kit sold with Catalog Number 701055604.
Check for the ECC Small Respiratory BEQ-TOP 5210 Custom Tubing Kit with Catalog Number 701055604. The product was sold with Lot 3000061303.
Inspect the seal between the device and housing for separation.
Yes, the seal separation could allow air entry, increasing resistance and causing blood flow drops in ECMO circuits, which may lead to serious complications.
Look for the ECC Small Respiratory BEQ-TOP 5210 Custom Tubing Kit with Catalog Number 701055604 and Lot 3000061303.
The recall record does not specify a remedy, so contact Datascope Corporation for guidance.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1727-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1727-2018 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.
