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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 24 of 34

Device	Model / Reference	Registries	Class	Status
Compass ™	613957	FDA UDI	Class II	Active
Mini Ghost™	612537	FDA UDI	Class II	Active
Mini Ghost™	612759	FDA UDI	Class II	Unknown
Mini Ghost™	613833	FDA UDI	Class II	Active
Mini Ghost™	612533	FDA UDI	Class II	Active
Z-Med Ii X™	618724	FDA UDI	Class II	Active
CP Stent™	614501	FDA UDI	Class III	Active
Mini Ghost™	612561	FDA UDI	Class II	Active
Z-Med Ii X™	618722	FDA UDI	Class II	Active
Z-Med Ii™	611705	FDA UDI	Class II	Active
Mini Ghost™	612518	FDA UDI	Class II	Active
Tyshak®	610608	FDA UDI	Class II	Unknown
Z-Med Ii X™	618700	FDA UDI	Class II	Active
Mini Ghost™	612584	FDA UDI	Class II	Unknown
Mini Ghost™	612656	FDA UDI	Class II	Unknown
Bib®	614428	FDA UDI	Class II	Active
Celsite	5430145	FDA UDI	Class II	Unknown
Accel®	613920	FDA UDI	Class I	Active
Bib®	614402	FDA UDI	Class II	Active
Impact™	254120	FDA UDI	Class II	Active
Compass ™	613970	FDA UDI	Class II	Active
Tyshak X™	618334	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612111	FDA UDI	Class II	Unknown
NuCLEUS-X™	612035	FDA UDI	Class II	Active
Asept®	622287	FDA UDI	Class II	Active
Mini Ghost™	612726	FDA UDI	Class II	Unknown
COEfficient™	611215	FDA UDI	Class III	Active
Tyshak®	610553	FDA UDI	Class II	Unknown
Accel®	613917	FDA UDI	Class I	Active
Mini Ghost™	613848	FDA UDI	Class II	Unknown
Tyshak®	610692	FDA UDI	Class II	Active
Tyshak®	610545	FDA UDI	Class II	Active
Bib®	614622	FDA UDI	Class II	Active
Mini Ghost™	612515	FDA UDI	Class II	Active
Celsite	5430095	FDA UDI	Class II	Active
Z-Med™	610242	FDA UDI	Class II	Active
Z-Med™	610463	FDA UDI	Class II	Active
Pts-X™	613747	FDA UDI	Class II	Unknown
Mini Ghost™	613832	FDA UDI	Class II	Unknown
Pts®	613705	FDA UDI	Class II	Active
Mini Ghost™	612762	FDA UDI	Class II	Unknown
Accel®	613929	FDA UDI	Class I	Active
Bib®	614630	FDA UDI	Class II	Active
Z-Med™	610483	FDA UDI	Class II	Active
Tyshak Ii®	611938	FDA UDI	Class II	Active
NuDEL	614566	FDA UDI	Class III	Active
CP Stent™	614354	FDA UDI	Class III	Active
Mini Ghost™	612516	FDA UDI	Class II	Active
Z-Med Ii™	611720	FDA UDI	Class II	Active
Z-Med™	610235	FDA UDI	Class II	Active

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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.