Datascope recalls Small Patient ECC Pack BEQ-TOP 22301 (Catalog No. 701049513) 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 Small Patient ECC Pack BEQ-TOP 22301 devices because a seal issue might let air into the device, reducing blood flow in ECMO circuits. This could lead to serious complications for patients using extracorporeal membrane oxygenation.
The seal between the device housing and the balloon can separate, allowing air to enter the housing. This air can collapse the balloon, increasing resistance in the venous line and reducing blood flow through the ECMO circuit.
Patients using ECMO (extracorporeal membrane oxygenation) systems with this specific device are most at risk. Healthcare providers who use the device for medical treatments may also be affected.
Check for the model 'BEQ-TOP 22301' with catalog number 701049513. The device was sold with lot number 3000060036.
Inspect the seal between the housing and balloon for separation. If air enters, stop use immediately.
The recall states that seal separation can occur, but the device is safe if the seal remains intact.
Look for the model 'BEQ-TOP 22301' with catalog number 701049513 and lot number 3000060036.
Check the seal for separation. If air enters, stop use immediately. The manufacturer does not provide a specific remedy for this recall.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1707-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1707-2018 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.
