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Circulatory Technology, Inc.

Last updated May 31, 2026

Information

Device	Model / Reference	Registries	Class	Status
Better-Bladder	BB14	FDA UDI	Class II	Active
Bigger Better-Bladder	BBB38	FDA UDI	Class II	Active
The V Bag, Catalog Number Vb1800; Vac-Box For Vacuum Assisted Venous Drainage, Catalog Number Vacbox1500	K012942	FDA 510(k)	Class II	Active
Initary Better Bladder-Pediatric	K140321	FDA 510(k)	Class II	Active
Better-Tubing	K964205	FDA 510(k)	Class II	Active
Better-Bladder (bb)	K981284	FDA 510(k)	Class II	Active
Pressure Relief Valve	K941492	FDA 510(k)	Class II	Active
The V-Bag	K001822	FDA 510(k)	Class II	Active
Better-Venter	K961594	FDA 510(k)	Class II	Active
Better-Bladder (bb)	K964337	FDA 510(k)	Class II	Active
Pressure Infusion Cuff	K942933	FDA 510(k)	Class I	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 27, 2021	Z-1862-2021	—	open, classified	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.
Sep 22, 2017	Z-0817-2018	—	terminated	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.
Sep 22, 2017	Z-1171-2018	—	terminated	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.
Jul 1, 2016	Z-2832-2016	—	terminated	The seal between the balloon and the housing may leak.
Jul 1, 2016	Z-0057-2017	—	terminated	Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Mar 3, 2016	Z-2050-2016	—	terminated	The seal between the balloon and the housing may leak.
Jun 3, 2009	Z-1323-2010	—	terminated	During an FDA inspection, it was discovered that the firm had conducted a silent recall of its Bigger Better Bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow.