Datascope recalls BEQ-TOP 38900 ECC Pack with custom tubing kits due to potential air entry causing blood flow drops in ECMO circuits. Affected units have catalog number 701056368.
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 38900 ECC Packs with custom tubing kits because a seal issue might let air enter the device, reducing blood flow in ECMO circuits. This could lead to serious complications for patients using extracorporeal membrane oxygenation.
The seal in the Better Bladder device can separate from the housing, allowing air to enter the device. This air entry increases resistance in the venous line, which may cause a drop in blood flow through the ECMO circuit.
Patients using ECMO systems with this specific tubing kit are most at risk. Healthcare providers who have purchased the recalled product may need to check their equipment.
Check for the catalog number 701056368 on the BEQ-TOP 38900 ECC Pack. The product was sold with lot number 3000060487.
Look for catalog number 701056368 on the BEQ-TOP 38900 ECC Pack with custom tubing kits.
Yes, the seal separation could allow air entry, increasing resistance and causing blood flow drops in ECMO circuits.
Check for catalog number 701056368 on the BEQ-TOP 38900 ECC Pack with custom tubing kits.
The recall 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-1719-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1719-2018 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.
