The Recall Desk
HighFDA (Devices)·Z-1862-2021·Announced 2021-06-23

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.

What this means for you

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.
Category
Medical Device — Extracorporeal Membrane Oxygenation
Hazard
  • device-collapse
  • blood-flow-reduction

Distribution

Distributed nationwide across the United States.

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