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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 17 of 34

Device	Model / Reference	Registries	Class	Status
Mini Ghost™	612543	FDA UDI	Class II	Active
Tyshak X™	618336	FDA UDI	Class II	Active
G-Armor Stent®	614743	FDA UDI	Class III	Active
Compass ™	613967	FDA UDI	Class II	Active
Z-Med™	611554	FDA UDI	Class II	Active
CP Stent™	614321	FDA UDI	Class III	Active
G-Armor Stent®	614804	FDA UDI	Class III	Active
Mini Ghost™	612556	FDA UDI	Class II	Unknown
COEfficient™	611208	FDA UDI	Class III	Active
Z-Med Ii™	611704	FDA UDI	Class II	Unknown
Tyshak Ii®	611922	FDA UDI	Class II	Active
Tyshak®	611561	FDA UDI	Class II	Unknown
Z-Med Ii X™	618738	FDA UDI	Class II	Active
Tyshak®	610625	FDA UDI	Class II	Active
Tyshak®	611526	FDA UDI	Class II	Active
Bib®	614409	FDA UDI	Class II	Active
Mini Ghost™	613801	FDA UDI	Class II	Active
CP Stent™	614328	FDA UDI	Class III	Active
NuCLEUS-X™	612027	FDA UDI	Class II	Active
Z-Med Ii X™	618746	FDA UDI	Class II	Active
Tyshak®	610632	FDA UDI	Class II	Unknown
B.braun	612133	FDA UDI	Class II	Active
Tyshak Ii®	611654	FDA UDI	Class II	Active
CP Stent™	614312	FDA UDI	Class III	Active
CP Stent™	614373	FDA UDI	Class III	Active
Multi-Snare®	612972	FDA UDI	Class II	Unknown
NuDEL	614576	FDA UDI	Class III	Active
Z-Med Ii™	611675	FDA UDI	Class II	Active
Bib®	614441	FDA UDI	Class II	Active
Tyshak Ii®	611909	FDA UDI	Class II	Active
G-Armor Stent®	614772	FDA UDI	Class III	Active
Tyshak Ii®	611915	FDA UDI	Class II	Active
Tyshak®	610675	FDA UDI	Class II	Unknown
CP Stent™	614300	FDA UDI	Class III	Active
CP Stent™	614383	FDA UDI	Class III	Active
Tyshak X™	618329	FDA UDI	Class II	Active
Mini Ghost™	612737	FDA UDI	Class II	Unknown
Tyshak X™	618321	FDA UDI	Class II	Active
Bib®	614636	FDA UDI	Class II	Active
Tyshak®	610508	FDA UDI	Class II	Active
Z-Med Ii™	611660	FDA UDI	Class II	Active
Bib®	614432	FDA UDI	Class II	Active
Mini Ghost™	612677	FDA UDI	Class II	Unknown
Accel®	612143	FDA UDI	Class I	Active
CP Stent™	614556	FDA UDI	Class III	Active
Z-Med Ii™	611653	FDA UDI	Class II	Active
Accel®	613908	FDA UDI	Class I	Active
CP Stent™	614518	FDA UDI	Class III	Active
Tyshak®	610655	FDA UDI	Class II	Unknown
B.braun	612154	FDA UDI	Class II	Active

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Authorised Representatives

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Importers

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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.