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The Better-Bladder (BB), part of extracorporeal membrane… recallZ-1862-2021 · Circulatory Technology Inc. · initiated Apr 27, 2021

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

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

Recall details

Recall number
Z-1862-2021
Status
Open, Classified
Initiated by the company
Apr 27, 2021
Recalling firm
Circulatory Technology Inc.
Quantity
147 units
Product code
DTN
FDA submissions
K981284
Distribution
US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.

Product description

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

Code information (models, lots, serial numbers)

Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K981284 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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