The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE recallZ-0057-2017 · Circulatory Technology Inc · initiated Jul 1, 2016
Class III Terminated All recalls posted in October 2016
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
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
FDA root cause category: Use error
What the company is doing
The firm, Circulatory Technology Inc., sent an "Urgent: Device Recall" letter dated July 1, 2016 and response forms to their customers via email. The letter described the product, problem and actions to be taken. The letter instructed customers to immediately inspect their inventory visually for units with wrinkled or twisted balloons and quarantine. Customers were also advised to complete and return the response form via email to [email protected]. Customers with questions are asked to contact Yehuda Tamari at (516) 624-2424, Monday to Friday, 9:00 AM - 7:00 PM, EST.
Recall details
- Recall number
- Z-0057-2017
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Jul 1, 2016
- Posted by the FDA
- Oct 7, 2016
- Recalling firm
- Circulatory Technology Inc
- Quantity
- 958 units
- Product code
- DTN
- FDA submissions
- K981284
- Distribution
- US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
Product description
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Code information (models, lots, serial numbers)
Lot Numbers: R19229, 015323, 014882, 014602 & 014601
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
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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