Class 2 Device Recall The BetterBladder

• Date Initiated by Firm: April 27, 2021
• Create Date: June 15, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1862-2021
• Recall Event ID: 88000
• 510(K)Number: K981284
• Product Classification: Reservoir, blood, cardiopulmonary bypass - Product Code DTN
• Product: The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
• Code Information: Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021
• Recalling Firm/ Manufacturer: Circulatory Technology Inc.; 21 Singworth St; Oyster Bay NY 11771-3703
• For Additional Information Contact: Yehuda Tamari; 516-624-2424
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: On April 27, 2021, CTI issued an Urgent Medical Device Removal notice to customers via email and phone, notifying them three better bladder BB14 units were found to have the pigtails dislodge from the housing. We are requesting that you immediately inspect your 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. Replacement BB14 from an unaffected lot will be available for shipping early next week. However, if you need to use the BB14 from the affected lot then, prior to its use, you must pull on the pigtail of the Better-Bladder to test its bond integrity. This can be achieved by connecting a 5cc syringe to the Luer of the pigtail, holding the housing and stretching the pigtail about ¿ inch. If the pigtail dislodges return the unit for credit or replacement. After the pull test be sure to conduct the leak test described in the Instructions for Use and copied below: Check the seals and connections of the BB as follows: isolate the BB from the rest of the circuit by clamping off (using tubing clamps) its inlet and outlet tubing, turn stopcock S1 to connect all three ports, pull on the 10cc syringe until the pressure monitor indicates a negative pressure of approximately 100mmHg. Turn the stopcock off to the syringe but open between the BB and the transducer. Maintain that negative pressure for at least one minute. Observe the pressure indicator to assure its reading does not drift upward (from a negative value towards atmosphere) from its initial pressure reading. A change in pressure indicates that air is leaking into the housing (not the blood path) of the BB. A slight initial increase in pressure (less negative) may occur due to contraction of the components. If the pressure continues to drift upward (less negative), you have a leak. Ensure that all air- filled connect
• Quantity in Commerce: 147 units
• Distribution: US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DTN and Original Applicant = CIRCULATORY TECHNOLOGY, INC.