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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 10 of 34

Device	Model / Reference	Registries	Class	Status
CP Stent™	614530	FDA UDI	Class III	Active
CP Stent™	614537	FDA UDI	Class III	Active
Z-Med X™	618409	FDA UDI	Class II	Unknown
G-Armor Stent®	614811	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612113	FDA UDI	Class II	Unknown
G-Armor Stent®	614793	FDA UDI	Class III	Active
Bib®	614424	FDA UDI	Class II	Active
Tyshak®	610530	FDA UDI	Class II	Active
CP Stent™	614384	FDA UDI	Class III	Active
Compass ™	613961	FDA UDI	Class II	Active
TYSHAK Mini®	611989	FDA UDI	Class II	Active
Bib®	614404	FDA UDI	Class II	Active
Bib®	614623	FDA UDI	Class II	Active
Z-Med™	610441	FDA UDI	Class II	Active
CP Stent™	614520	FDA UDI	Class III	Active
Z-5™	611100	FDA UDI	Class II	Active
Mini Ghost™	612563	FDA UDI	Class II	Unknown
TYSHAK NuCLEUS™	612072	FDA UDI	Class II	Active
Tyshak Ii®	611798	FDA UDI	Class II	Unknown
Z-Med X™	618434	FDA UDI	Class II	Active
Mini Ghost™	612577	FDA UDI	Class II	Unknown
Mini Ghost™	612560	FDA UDI	Class II	Active
Tyshak Ii®	611539	FDA UDI	Class II	Active
G-Armor Stent®	614721	FDA UDI	Class III	Active
Tyshak®	610526	FDA UDI	Class II	Active
TYSHAK Mini®	612013	FDA UDI	Class II	Active
Elite HV®	612909	FDA UDI	Class II	Active
Tyshak®	611154	FDA UDI	Class II	Active
Z-Med X™	618446	FDA UDI	Class II	Active
G-Armor Stent®	614801	FDA UDI	Class III	Active
Mini Ghost™	612709	FDA UDI	Class II	Active
Z-Med™	610479	FDA UDI	Class II	Active
Mullins X™	618811	FDA UDI	Class II	Active
Z-Med X™	618436	FDA UDI	Class II	Active
CP Stent™	614480	FDA UDI	Class III	Active
Bib®	614632	FDA UDI	Class II	Active
Z-Med Ii X™	618750	FDA UDI	Class II	Active
Asept	622273	FDA UDI	Class II	Active
Z-Med Ii X™	618745	FDA UDI	Class II	Active
Tyshak Ii®	611910	FDA UDI	Class II	Active
Impact™	164120	FDA UDI	Class II	Active
Impact™	142120	FDA UDI	Class II	Active
Mini Ghost™	612541	FDA UDI	Class II	Active
Z-Med Ii™	611736	FDA UDI	Class II	Active
Z-Med X™	618418	FDA UDI	Class II	Unknown
Mini Ghost™	612522	FDA UDI	Class II	Unknown
Tyshak®	611159	FDA UDI	Class II	Unknown
CP Stent™	614361	FDA UDI	Class III	Active
Z-Med™	610476	FDA UDI	Class II	Active
Z-Med X™	618402	FDA UDI	Class II	Unknown

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Authorised Representatives

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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.