Z-1862-2021Class II

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

Name: Z-1862-2021 The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits...
Creator: Circulatory Technology Inc.
Published: 2021-04-27
License: https://open.fda.gov/license/

Circulatory Technology, Inc. / initiated 2021-04-27 / Open, Classified / root cause: manufacturing process

FDA source

Circulatory Technology Inc. began a recall of The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14 on 2021-04-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1862-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-27
Posted: 2021-06-15
Recalling firm: Circulatory Technology, Inc.
Product: The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Product code: DTN Reservoir, Blood, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1862-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1862-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-23	2021-06-15

Product code DTN

K981284Class IIBetter-Bladder (Bb)Circulatory Technology, Inc. / cleared 1998-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)