Datascope recalls BEQ-TOP 22300 Custom Tubing Kit (Catalog 701049504) due to potential air entry causing ECMO blood flow drops. Affected units include specific lots.
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 its BEQ-TOP 22300 Custom Tubing Kit because a seal issue could let air enter the device, reducing blood flow in ECMO circuits. This poses a risk to patients using extracorporeal membrane oxygenation systems.
The tubing kit's seal can separate, allowing air to enter the device housing. This may collapse the balloon and increase resistance in the venous line, reducing blood flow through the ECMO circuit. This could lead to inadequate oxygenation for patients.
Patients using ECMO systems with this tubing kit are at risk. Healthcare providers who use the kit for medical treatments may need to act quickly.
Check for the BEQ-TOP 22300 Custom Tubing Kit with Catalog Number 701049504. Affected units include specific production lots: 3000057378 and 3000061216.
Identify the catalog number and production lots to confirm if your unit is affected.
Yes, the seal separation could allow air to enter the device, potentially reducing blood flow in ECMO circuits.
The official recall notice does not specify a remedy, so check the product details to see if it's affected.
Look for the BEQ-TOP 22300 Custom Tubing Kit with Catalog Number 701049504 and production lots 3000057378 or 3000061216.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1729-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1729-2018 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.
