Datascope recalls BEQ-TOP 40700 HUNTINGTON tubing kits due to potential air entry causing ECMO blood flow drops. Affected units have catalog number 701062899.
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 40700 HUNTINGTON tubing kits because air could enter the device and reduce blood flow in ECMO circuits. This could cause dangerous drops in blood flow for patients using extracorporeal membrane oxygenation.
The tubing kit's seal may separate, letting air into the device. This can collapse the balloon and increase resistance in the venous line, reducing blood flow through the ECMO circuit.
Patients using ECMO systems with this specific tubing kit are at risk. Healthcare providers who have the catalog number 701062899 are most affected.
Check for the catalog number 701062899 on the tubing kit. The product was sold with lot number 3000057630.
Inspect the tubing kit for seal separation that might allow air to enter the housing.
The recall states that seal separation could allow air entry, which may reduce blood flow in ECMO circuits. This is a specific hazard for patients using ECMO systems.
Look for catalog number 701062899 on the tubing kit, which was sold with lot number 3000057630.
The recall does not specify a remedy, so check with your healthcare provider about potential risks and next steps.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1711-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1711-2018 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.
