Datascope recalls neonatal ECMO tubing kits with potential air entry risk causing blood flow drops. Affected units have specific catalog numbers and lots. Contact for remedy.
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 neonatal ECMO tubing kits that may allow air to enter the circuit, reducing blood flow. This could cause serious complications for infants on ECMO support.
The tubing kit's seal may separate, letting air enter the housing. This can collapse the balloon and increase resistance in the venous line, reducing blood flow through the ECMO circuit.
Infants using ECMO support systems with the recalled tubing kits. Healthcare providers and neonatal care facilities are most at risk.
Check for catalog number 709000069R02 and lot number 3000061507 on the packaging. The product is sold as a neonatal ECMO tubing kit.
Identify the catalog number 709000069R02 and lot number 3000061507 on the packaging.
Yes, the seal may separate allowing air to enter the housing, which could reduce blood flow in the ECMO circuit.
The recall record does not specify a remedy, so contact Datascope for guidance.
Look for catalog number 709000069R02 and lot number 3000061507 on the packaging.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1720-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1720-2018 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.
