Circulatory Technology Better-Bladder BB14: Risk of Circuit Collapse During ECMO Use
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.
Stop using this now
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.
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What happened, in plain English
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. Read more at govinfonow.com/recall/62696-circulatory-technology-better-bladder-bb14-risk-of-circuit-collapse-during.
Source Summary by GovInfoNow · govinfonow.com/recall/62696-circulatory-technology-better-bladder-bb14-risk-of-circuit-collapse-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1862-2021
Cite this page
“Circulatory Technology Better-Bladder BB14: Risk of Circuit Collapse During ECMO Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62696-circulatory-technology-better-bladder-bb14-risk-of-circuit-collapse-during. Based on FDA recall #Z-1862-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1862-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Circulatory Technology- Product
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14- Category
Medical device
What to do — step by step
Stop Using Immediately
The Better-Bladder BB14 may collapse during ECMO use, causing reduced blood flow. Discontinue use immediately.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
FDA distribution: “US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, District of Columbia, Florida, Georgia, Indiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas.
Recall timeline
FDA published this recall 57 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1862-2021 (April 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1862-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.