Circulatory Technology recalls The Better-Bladder BB14 ECMO circuit component due to potential collapse during use, which may cause reduced blood flow. Affected units have specific model and lot numbers.
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
Circulatory Technology recalls The Better-Bladder BB1:4 ECMO circuit component because it may collapse during use, causing reduced blood flow. This is a serious risk for patients using ECMO life support systems.
The Better-Bladder may collapse during ECMO use, increasing resistance in the venous line and reducing blood flow. This can lead to inadequate oxygenation and serious complications for patients on life support.
Patients using ECMO life support systems with the Better-Bladder BB14 model are affected. Healthcare providers using this specific circuit component are at highest risk.
Check for model BB14 on the device. Affected units have lot number 5290-201001 and UDI (Unique Device Identification) code (01)00851997007004(10)5290-201001(17)20231021(11)20201021.
The Better-Bladder BB14 may collapse during ECMO use, causing reduced blood flow. Discontinue use immediately.
The Better-Bladder BB14 is a component used in extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits.
Collapse may increase resistance in the venous line and cause reduced blood flow, potentially leading to serious complications.
Check for model BB14, lot number 5290-201001, and UDI code (01)00851997007004(10)5290-201001(17)20231021(11)20201021.
We’ve drafted a message you can send Circulatory Technology to request your refund or repair — edit it as you like.
Subject: Recall Z-1862-2021 — Circulatory Technology Circulatory Technology Hello, I own a Circulatory Technology that is covered by recall Z-1862-2021 from Circulatory Technology. 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.
