Datascope recalls BEQ-TOP 22701 tubing kits for potential air entry into ECMO circuits, risking blood flow drops. Affected units have specific catalog numbers and 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 certain BEQ-TOP 22701 tubing kits used in ECMO systems because a seal failure could let air into the circuit, reducing blood flow. This poses a risk of serious complications for patients on life support.
The seal between the tubing and housing can separate, allowing air to enter the ECMO circuit. This air can collapse the balloon, increasing resistance and reducing blood flow through the venous line, which may cause serious complications for patients on life support.
Patients using ECMO (extracorporeal membrane oxygenation) systems with the recalled tubing kits are most at risk. Healthcare providers who use these kits for custom tubing solutions may also be affected.
Check for the catalog number 701050790 on the tubing kit. Affected units include specific lots: 3000060359 and 3000062725. The product is sold as part of custom tubing kits for ECMO systems.
Identify the catalog number 701050790 and lot numbers 3000060359 or 3000062725 on the tubing kit.
Yes, the recall is for ECMO tubing kits where seal separation could allow air entry, potentially reducing blood flow and causing serious complications.
The official recall record does not specify a remedy or action steps beyond identifying the affected units.
Look for catalog number 701050790 and lot numbers 3000060359 or 3000062725 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-1714-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1714-2018 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.
