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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 20 of 34

Device	Model / Reference	Registries	Class	Status
Z-Med Ii™	611659	FDA UDI	Class II	Active
COEfficient™	611688	FDA UDI	Class III	Active
NuDEL	614582	FDA UDI	Class III	Active
D'vill™	612845	FDA UDI	Class II	Active
NuDEL	614575	FDA UDI	Class III	Active
Compass ™	613959	FDA UDI	Class II	Active
Z-Med™	610233	FDA UDI	Class II	Active
Bib®	614415	FDA UDI	Class II	Active
Z-Med Ii™	611733	FDA UDI	Class II	Active
Z-Med™	611683	FDA UDI	Class II	Active
Z-Med™	610638	FDA UDI	Class II	Active
Bib®	614396	FDA UDI	Class II	Active
CP Stent™	614315	FDA UDI	Class III	Active
Mini Ghost™	612720	FDA UDI	Class II	Unknown
Elite HV®	612930	FDA UDI	Class II	Active
G-Armor Stent®	614716	FDA UDI	Class III	Active
Accel®	612142	FDA UDI	Class II	Active
Tyshak®	610504	FDA UDI	Class II	Unknown
Accel®	613916	FDA UDI	Class II	Active
G-Armor Stent®	614767	FDA UDI	Class III	Active
TYSHAK Mini®	611996	FDA UDI	Class II	Active
G-Armor Stent®	614724	FDA UDI	Class III	Active
Celsite	5436717	FDA UDI	Class II	Active
Pts-X™	613717	FDA UDI	Class II	Active
Asept®	622288	FDA UDI	Class II	Active
Micro-Access Elite®	613361	FDA UDI	Class II	Unknown
CP Stent™	614352	FDA UDI	Class III	Active
Tyshak®	610548	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612070	FDA UDI	Class II	Active
Mullins X™	618813	FDA UDI	Class II	Active
Mini Ghost™	612503	FDA UDI	Class II	Unknown
Tyshak X™	618337	FDA UDI	Class II	Active
Tyshak X™	618317	FDA UDI	Class II	Active
CP Stent™	614322	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612078	FDA UDI	Class II	Unknown
Mini Ghost™	612728	FDA UDI	Class II	Unknown
Z-Med Ii™	611788	FDA UDI	Class II	Active
Mini Ghost™	612552	FDA UDI	Class II	Active
Mullins X™	618814	FDA UDI	Class II	Active
Pts-X™	613746	FDA UDI	Class II	Active
Mini Ghost™	612549	FDA UDI	Class II	Active
Z-Med X™	618430	FDA UDI	Class II	Active
Tyshak®	610603	FDA UDI	Class II	Unknown
Z-Med Ii X™	618728	FDA UDI	Class II	Active
NuDEL	614581	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612067	FDA UDI	Class II	Active
Mini Ghost™	612553	FDA UDI	Class II	Unknown
G-Armor Stent®	614754	FDA UDI	Class III	Active
Tyshak X™	618307	FDA UDI	Class II	Unknown
Accel™	470191	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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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.