Datascope recalls BEQ-TOP 24202 Adult ECMO bladders with potential air entry causing blood flow drops. Affected units have specific catalog and lot numbers. Stop using immediately.
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 adult ECMO bladders that may allow air to enter the housing, reducing blood flow in the ECMO circuit. This could cause serious complications for patients using extracorporeal membrane oxygenation therapy.
The bladder's seal may separate from the housing, letting air enter the system. This can increase resistance in the venous line and reduce blood flow through the ECMO circuit, potentially causing serious complications for patients.
Patients using extracorporeal membrane oxygenation (ECMO) therapy with this specific bladder model are most at risk. Healthcare providers who have purchased or use these bladders in medical settings may also be affected.
Check for the product name 'BEQ-TOP 24202 ADULT ECC' with catalog number 701054295. Affected units have specific lot numbers: 3000057379, 3000063707, or 3000066885.
Discard the BEQ-TOP 24202 ADULT ECC bladder if it has the affected catalog or lot numbers.
The seal separation from the housing may allow air to enter the system, increasing resistance and causing blood flow drops in the ECMO circuit.
Catalog number 701054295 with lot numbers 3000057379, 3000063707, or 3000066885.
This could cause reduced blood flow in the ECMO circuit, potentially leading to serious complications for patients on extracorporeal membrane oxygenation therapy.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1715-2018 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1715-2018 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.
