# Circulatory Technology, Inc. > Medical device manufacturer record on deviCERTS, compiled from public registries. Circulatory Technology, Inc. is a medical device manufacturer, with 11 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) and 7 FDA recalls as of 15 Nov 2026. - Canonical page: - Country: United States (FDA applicant, unverified) - Role: Manufacturer - DUNS: 786778944 ## Figures - Devices: 11 - FDA recalls (matched to the firm by name): 7, 1 ongoing ## Registry facts *Every device of the manufacturer. A device listed in two registries counts in both.* - Registries: FDA 510(k) 9, FDA GUDID 2 - Device classes: FDA Class II 10, FDA Class I 1 ## Devices The first 11 of 11, in the order of the canonical page, which lists them all. - [Better-Bladder BB14](https://devicerts.com/devices/better-bladder-bb14) · Class II · GUDID · status: Active · open recall - [Bigger Better-Bladder BBB38](https://devicerts.com/devices/bigger-better-bladder-bbb38) · Class II · GUDID · status: Active · open recall - [The V Bag, Catalog Number VB1800; Vac-Box For Vacuum Assisted Venous Drainage, Catalog Number VACBOX1500](https://devicerts.com/devices/the-v-bag-catalog-number-vb1800-vac-box-for-vacuum-assisted-dtn) · ref K012942 · Class II · 510(k) · status: Active · decision 2001-11-05 - [Initary Better Bladder-Pediatric](https://devicerts.com/devices/initary-better-bladder-pediatric-dtn) · ref K140321 · Class II · 510(k) · status: Active · decision 2014-04-17 - [Better-Tubing](https://devicerts.com/devices/better-tubing-dwf) · ref K964205 · Class II · 510(k) · status: Active · decision 1998-04-08 - [Better-Bladder (Bb)](https://devicerts.com/devices/better-bladder-bb-dtn) · ref K981284 · Class II · 510(k) · status: Active · decision 1998-08-12 · open recall - [Pressure Relief Valve](https://devicerts.com/devices/pressure-relief-valve-mnj) · ref K941492 · Class II · 510(k) · status: Active · decision 1994-10-26 - [The V-Bag](https://devicerts.com/devices/the-v-bag-dtn) · ref K001822 · Class II · 510(k) · status: Active · decision 2000-07-07 - [Better-Venter](https://devicerts.com/devices/better-venter-dwf) · ref K961594 · Class II · 510(k) · status: Active · decision 1996-09-05 - [Better-Bladder (Bb)](https://devicerts.com/devices/better-bladder-bb-fib) · ref K964337 · Class II · 510(k) · status: Active · decision 1997-05-23 - [Pressure Infusion Cuff](https://devicerts.com/devices/pressure-infusion-cuff-kzd) · ref K942933 · Class I · 510(k) · status: Active · decision 1994-08-25 ## FDA recalls (matched by name, newest first) - Z-1862-2021 · Class II · Ongoing · initiated 2021-04-27 · product code DTN: 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. - Z-0817-2018 · Class II · Terminated · initiated 2017-09-22 · product code DTN: 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. - Z-1171-2018 · Class II · Terminated · initiated 2017-09-22 · product code DTN: 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. - Z-0057-2017 · Class III · Terminated · initiated 2016-07-01 · product code DTN: Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm. - Z-2832-2016 · Class II · Terminated · initiated 2016-07-01 · product code DTN: The seal between the balloon and the housing may leak. - Z-2050-2016 · Class II · Terminated · initiated 2016-03-03 · product code DTN: The seal between the balloon and the housing may leak. - Z-1323-2010 · Unclassified (pre-2012) · Terminated · initiated 2009-06-03 · product code DTN: 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. ## Source and citation - Cite as: Circulatory Technology, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/circulatory-technology-inc (data as of 2026-11-15). - Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - FDA recall data as of: 2026-11-01 - Data as of: 2026-11-15 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/manufacturers/circulatory-technology-inc - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.