Better-Bladder cardiopulmonary bypass blood reservoir recallZ-0817-2018 · Circulatory Technology Inc · initiated Sep 22, 2017
Class II Terminated All recalls posted in March 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Circulatory Technology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
The firm is requesting that consignees immediately inspect inventory, and quarantine all units having the aforementioned lots. These units must be returned to CTI. CTI will provide UPS shipping labels for returning the units and will provide replacements or credit for the returned units. Should the inventory consist of only the affected lots then, until the consignee receives replacement BB14s from an unaffected lot, the firm recommends using the BB14 from the affected lots only if, prior to its use, they pull on the pigtail of the Better-Bladder to test its bond integrity prior to its use. If the pigtail dislodges then return the unit for credit or replacement. The consignees should complete and return the enclosed response form via email to [email protected] as soon as possible.
Recall details
- Recall number
- Z-0817-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 22, 2017
- Posted by the FDA
- Mar 1, 2018
- Recalling firm
- Circulatory Technology Inc
- Quantity
- 840
- Product code
- DTN
- FDA submissions
- K981284
- Distribution
- **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
Product description
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Code information (models, lots, serial numbers)
**Recall expanded to add additional lot numbers highlighted with "**": BB14 Lot Numbers: 5290-S19785, 5290-S19786, 5290-S19872, **5290-S19925; BB14NS Lot Numbers: 17062201, 17062202, 17062203, and **170905
Other devices under the same FDA submission
2 devices cleared under K981284 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Better-Bladder BB14Circulatory Technology Inc · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS1 recall5 reports
- Bigger Better-Bladder BBB38Circulatory Technology Inc · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 79196).
- Z-1171-2018 · Terminated**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manu…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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