Better-Bladder ECMO Device May Collapse, Reducing Blood Flow
The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall where the device may collapse during use, reducing blood flow in critical ECMO circuits. No illnesses or injuries are reported in the source, but the potential hazard is significant. This meets the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Circulatory Technology Inc. is recalling the Better-Bladder (BB) Model BB14, a component used in extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. The recall affects 147 units distributed nationwide.
The Better-Bladder device may collapse during use, which increases resistance to flow in the venous line and causes a drop in circuit blood flow. This malfunction poses a serious risk to patients who depend on the ECMO circuit for cardiopulmonary support.
Healthcare facilities and clinicians should immediately discontinue use of affected units from lot number 5290-201001. Circulatory Technology Inc. has issued this Class II recall and should be contacted for replacement options and further guidance.
The recalled product
- Product
- The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
- Manufacturer
- Circulatory Technology Inc.
- Affected units
- 147
Distribution
Related recalls
Same manufacturer · Circulatory Technology Inc.
See all →- SevereCirculatory Technology Recalls Cardiopulmonary Bypass Blood Reservoirs
FDA (Devices) · 2018-03-07
- SevereCirculatory Technology Recalls Better-Bladder ECMO Blood Reservoirs
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- LowCirculatory Technology Recalls Better-Bladder Devices Due to Cosmetic Defects
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Similar recalls
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FDA (Devices) · 2018-03-07
- SevereCirculatory Technology Recalls Cardiopulmonary Bypass Blood Reservoirs
FDA (Devices) · 2018-03-07
- SevereDatascope Better Bladder Device Recalled Due to Seal Separation Risk
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- SevereDatascope recalls Better Bladder device due to seal separation risk
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- SevereDatascope recalls Better Bladder device in custom tubing kits
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- LowCirculatory Technology Recalls Better-Bladder Devices Due to Cosmetic Defects
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