Datascope recalls BO-TOP 13901 Rapid Response Custom Tubing Kit (Catalog 701054874) 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 BO-TOP 13901 Rapid Response Custom Tubing Kits because a seal issue might let air into the device, reducing blood flow in ECMO systems. This could lead to serious complications for patients using extracorporeal membrane oxygenation.
The seal between the tubing and housing can separate, allowing air to enter the device. This air can collapse the balloon, increasing resistance in the venous line and reducing blood flow through the ECMO circuit.
Patients using ECMO systems with this specific tubing kit may be affected. Healthcare providers who use the kit for medical treatments are most at risk.
Check for the catalog number 701054874 on the tubing kit. The product was sold with lot number 3000067221.
Inspect the tubing kit for seal separation that might allow air to enter the housing.
Yes, the seal separation could allow air to enter the housing, potentially reducing blood flow in ECMO circuits.
Look for catalog number 701054874 and lot number 3000067221 on the tubing kit.
The recall record 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-1731-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1731-2018 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.
