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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 26 of 34

Device	Model / Reference	Registries	Class	Status
Impact™	144120	FDA UDI	Class II	Active
Z-Med™	612060	FDA UDI	Class II	Active
G-Armor Stent®	614763	FDA UDI	Class III	Active
CP Stent™	614332	FDA UDI	Class III	Active
Tyshak®	610540	FDA UDI	Class II	Active
Z-Med™	610461	FDA UDI	Class II	Active
Mini Ghost™	613808	FDA UDI	Class II	Unknown
CP Stent™	614546	FDA UDI	Class III	Active
Tyshak®	610519	FDA UDI	Class II	Unknown
Tyshak®	610512	FDA UDI	Class II	Unknown
Tyshak®	611415	FDA UDI	Class II	Active
Celsite	5432460	FDA UDI	Class II	Active
G-Armor Stent®	614780	FDA UDI	Class III	Active
Tyshak X™	618326	FDA UDI	Class II	Active
Mini Ghost™	612534	FDA UDI	Class II	Active
Z-Med Ii X™	618747	FDA UDI	Class II	Active
B.braun	5430144	FDA UDI	Class II	Unknown
Tyshak®	610611	FDA UDI	Class II	Unknown
Tyshak®	610531	FDA UDI	Class II	Active
Tyshak®	610535	FDA UDI	Class II	Active
Elite HV®	612818	FDA UDI	Class II	Active
TYSHAK Mini®	611994	FDA UDI	Class II	Active
Z-Med™	611823	FDA UDI	Class II	Active
Impact™	204120	FDA UDI	Class II	Active
Z-Med Ii™	611656	FDA UDI	Class II	Active
Z-Med™	610449	FDA UDI	Class II	Active
COEfficient™	611224	FDA UDI	Class III	Active
Tyshak X™	618335	FDA UDI	Class II	Active
Tyshak®	610648	FDA UDI	Class II	Active
Accel®	613914	FDA UDI	Class II	Active
Accel®	612141	FDA UDI	Class I	Active
Mini Ghost™	612562	FDA UDI	Class II	Active
Z-Med Ii™	611805	FDA UDI	Class II	Active
Z-Med Ii™	611755	FDA UDI	Class II	Active
Z-Med Ii™	611707	FDA UDI	Class II	Active
Z-Med™	610446	FDA UDI	Class II	Active
Mini Ghost™	612559	FDA UDI	Class II	Active
CP Stent™	614302	FDA UDI	Class III	Active
Tyshak®	610672	FDA UDI	Class II	Active
TYSHAK Mini®	612012	FDA UDI	Class II	Active
Z-Med™	611812	FDA UDI	Class II	Active
Bib®	614397	FDA UDI	Class II	Active
Z-Med X™	618450	FDA UDI	Class II	Active
Tyshak®	610618	FDA UDI	Class II	Active
Micro-Access Elite®	613354	FDA UDI	Class II	Unknown
Z-Med Ii™	611694	FDA UDI	Class II	Active
G-Armor Stent®	614774	FDA UDI	Class III	Active
Elite HV®	612806	FDA UDI	Class II	Active
Tyshak Ii®	611948	FDA UDI	Class II	Active
Z-Med™	611822	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.