Datascope recalls BO-TOP 20700 Small Patient 3/8 Custom Tubing Kit (Catalog 701050966) due to potential air entry in ECMO circuits causing blood flow drops.
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 20700 Small Patient 3/8 Custom Tubing Kits 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 may separate, allowing air to enter the device housing. This can collapse the balloon and increase resistance in the venous line, reducing blood flow in the ECMO circuit.
Patients using ECMO systems with this tubing kit are most at risk. The recall applies to specific model kits sold with catalog number 701050966.
Check for the catalog number 701050966 on the tubing kit. The product was sold with lot number 3000063810.
Inspect the tubing kit for seal separation that might allow air to enter the housing.
The recall indicates a potential risk of air entry causing blood flow drops, so it should not be used until the issue is addressed.
The official recall does not specify a remedy, so contact Datascope Corporation for guidance.
Look for catalog number 701050966 and lot number 3000063810 on the tubing kit.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1732-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1732-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
