# FDA recall Z-1862-2021

> **Circulatory Technology Inc.** · Class II · device recall initiated 2021-04-27.

## Product

The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits.   Model: BB14

## Reason for recall

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.

## Distribution

US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.

## Key facts

- **Recall number:** Z-1862-2021
- **Recalling firm:** Circulatory Technology Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-27
- **Report date:** 2021-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oyster Bay, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1862-2021

## Citation

> AI Analytics. FDA recall Z-1862-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1862-2021. Source: US FDA. Licensed CC0.

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