Datascope recalls BEQ-TOP 49101 Childrens Large ECC Pack with custom tubing kits 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 children's ECMO tubing kits because a seal issue might let air enter the device, reducing blood flow in life-support systems. This could lead to serious complications for patients using the equipment.
The seal between the device housing and the balloon can separate, allowing air to enter the housing. This may collapse the balloon and increase resistance in the venous line, reducing blood flow through the ECMO circuit.
Patients using the BEQ-TOP 49101 Childrens Large ECC Pack with custom tubing kits for ECMO support are most at risk. Healthcare providers managing these patients should check if they have the recalled model.
Check for the product name 'BEQ-TOP 49101 Childrens Large ECC Pack' with catalog number 701067069R01. The recall covers specific lots, including Lot 3000059724.
Verify the product name and catalog number to confirm if your item is recalled.
The seal separation may allow air to enter the housing, causing the balloon to collapse and reducing blood flow in ECMO circuits.
The recall record does not specify a remedy, so contact Datascope Corporation for guidance.
The hazard could cause reduced blood flow in ECMO circuits, which may lead to serious complications for patients.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1717-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1717-2018 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.
