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B BRAUN INTERVENTIONAL SYSTEMS, INC

Last updated May 24, 2026

What B BRAUN INTERVENTIONAL SYSTEMS, INC makes

The company manufactures interventional cardiovascular and vascular devices, including cardiac valvuloplasty catheters for treating narrowed heart valves, bare-metal and stent-graft systems for aortic interventions, and peripheral angioplasty balloons for treating blocked arteries. Additional products include vascular catheter introduction sets, vascular ports and catheters for long-term access, and multi-purpose drainage catheters for abdominal or thoracic fluid management. Cardiac sizing catheters are also part of the portfolio, used to measure valve annulus dimensions before procedures.

The device portfolio spans FDA device classes, with Class I products for minimally invasive accessories, Class II for moderate-risk items like angioplasty balloons and vascular ports, and Class III for high-risk interventions such as aortic stents and valvuloplasty catheters. All listed devices are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. The company is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: bbraun.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(877)836-2228
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 784259751

Catalogue (1693)

Page 23 of 34

Device	Model / Reference	Registries	Class	Status
TYSHAK NuCLEUS™	612073	FDA UDI	Class II	Active
Z-Med X™	618401	FDA UDI	Class II	Unknown
D'vill™	612847	FDA UDI	Class II	Active
SwitchBack™	622518	FDA UDI	Class II	Active
Mini Ghost™	613841	FDA UDI	Class II	Active
Mini Ghost™	612530	FDA UDI	Class II	Active
Compass ™	613972	FDA UDI	Class II	Active
CP Stent™	614538	FDA UDI	Class III	Active
Bib®	614460	FDA UDI	Class II	Active
Multi-Track™	615001	FDA UDI	Class II	Active
NuCLEUS-X™	612039	FDA UDI	Class II	Active
Asept®	622279	FDA UDI	Class II	Active
Tyshak Ii®	611931	FDA UDI	Class II	Active
Mullins X™	618807	FDA UDI	Class II	Active
Mini Ghost™	612548	FDA UDI	Class II	Active
NuCLEUS-X™	612037	FDA UDI	Class II	Active
CP Stent™	614479	FDA UDI	Class III	Active
CP Stent™	614504	FDA UDI	Class III	Active
Compass ™	613974	FDA UDI	Class II	Active
Accel®	613906	FDA UDI	Class II	Active
CP Stent™	614536	FDA UDI	Class III	Active
Mini Ghost™	613824	FDA UDI	Class II	Unknown
Celsite	5436709	FDA UDI	Class II	Active
Bib®	614626	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612090	FDA UDI	Class II	Active
Accel®	613931	FDA UDI	Class II	Active
Pts-X™	613751	FDA UDI	Class II	Active
Bib®	614391	FDA UDI	Class II	Active
Mullins X™	618812	FDA UDI	Class II	Active
Asept®	622273B	FDA UDI	Class II	Active
Z-Med Ii™	611739	FDA UDI	Class II	Active
Accel®	622299	FDA UDI	Class II	Active
Bib®	614451	FDA UDI	Class II	Active
Tyshak®	610557	FDA UDI	Class II	Unknown
Tyshak®	610502	FDA UDI	Class II	Unknown
Bib®	614447	FDA UDI	Class II	Active
Tyshak®	610537	FDA UDI	Class II	Active
Compass ™	613944	FDA UDI	Class II	Active
Bib®	614425	FDA UDI	Class II	Active
Z-Med Ii™	611759	FDA UDI	Class II	Active
G-Armor Stent®	614756	FDA UDI	Class III	Active
Tyshak Ii®	611919	FDA UDI	Class II	Active
Mini Ghost™	612505	FDA UDI	Class II	Active
Accel®	613902	FDA UDI	Class II	Active
Mini Ghost™	612716	FDA UDI	Class II	Unknown
Mini Ghost™	612708	FDA UDI	Class II	Active
Bib®	614446	FDA UDI	Class II	Active
Z-Med X™	618412	FDA UDI	Class II	Unknown
Mini Ghost™	612544	FDA UDI	Class II	Unknown
CP Stent™	614369	FDA UDI	Class III	Active

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Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (4)

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

B. Braun Interventional Systems, Inc. has four recall records initiated between October 30, 2007, and June 16, 2015, all of which are marked as terminated. The recalls involved incorrect components in needle accessories for Celsite Access Ports, reports of polyurethane catheter disconnections, out-of-specification endotoxin test results for peelable sheaths, and compromised package sealing on Tyvek pouches, leaving one edge partially open.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 16, 2015	Z-2382-2015	—	terminated	The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Apr 13, 2011	Z-2671-2011	—	terminated	The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into implanted Celsite Access Ports. Two winged Surecan needle sizes are provided in Celsite U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle
Jun 22, 2009	Z-1961-2009	—	terminated	B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical France has decided to recall all Celsite ports supplied with the affected catheter lot. To date, B. Braun Interventional Systems (US) has not received any reports of catheter dis
Oct 30, 2007	Z-0264-2008	—	terminated	Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.