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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 1 of 34

Device	Model / Reference	Registries	Class	Status
Compass ™	613980	FDA UDI	Class II	Active
CP Stent™	614512	FDA UDI	Class III	Active
NuDEL	614561	FDA UDI	Class III	Active
Z-Med™	610472	FDA UDI	Class II	Active
Elite HV®	612809	FDA UDI	Class II	Active
Compass ™	613952	FDA UDI	Class II	Active
NuDEL	614568	FDA UDI	Class III	Active
CP Stent™	614471	FDA UDI	Class III	Active
Pts-X™	613735	FDA UDI	Class II	Unknown
Mini Ghost™	612540	FDA UDI	Class II	Active
COEfficient™	611213	FDA UDI	Class III	Active
CP Stent™	614493	FDA UDI	Class III	Active
G-Armor Stent®	614776	FDA UDI	Class III	Active
Compass ™	613966	FDA UDI	Class II	Active
G-Armor Stent®	614741	FDA UDI	Class III	Active
Tyshak Ii®	611946	FDA UDI	Class II	Active
Z-Med Ii X™	618726	FDA UDI	Class II	Active
Z-Med Ii™	611726	FDA UDI	Class II	Active
Tyshak Ii®	611911	FDA UDI	Class II	Active
Micro-Access Elite®	613351	FDA UDI	Class II	Unknown
Tyshak®	610532	FDA UDI	Class II	Active
Pts®	613706	FDA UDI	Class II	Active
Elite HV®	612817	FDA UDI	Class II	Active
Z-Med Ii X™	618701	FDA UDI	Class II	Active
TYSHAK Mini®	611987	FDA UDI	Class II	Active
Bib®	614433	FDA UDI	Class II	Active
COEfficient™	611226	FDA UDI	Class III	Active
Bib®	614629	FDA UDI	Class II	Active
CP Stent™	614554	FDA UDI	Class III	Active
Multi-Snare®	612976	FDA UDI	Class II	Unknown
Pts-X™	613720	FDA UDI	Class II	Active
TYSHAK Mini®	611990	FDA UDI	Class II	Active
Mini Ghost™	612707	FDA UDI	Class II	Unknown
CP Stent™	614514	FDA UDI	Class III	Active
Tyshak Ii®	611551	FDA UDI	Class II	Active
Z-Med Ii X™	618730	FDA UDI	Class II	Active
Z-Med Ii™	611768	FDA UDI	Class II	Active
NuDEL	614567	FDA UDI	Class III	Active
Z-Med Ii™	611753	FDA UDI	Class II	Active
Mullins X™	618809	FDA UDI	Class II	Active
Z-Med™	611676	FDA UDI	Class II	Active
CP Stent™	614339	FDA UDI	Class III	Active
G-Armor Stent®	614766	FDA UDI	Class III	Active
Tyshak Ii®	611944	FDA UDI	Class II	Active
Mini Ghost™	612569	FDA UDI	Class II	Active
Z-Med Ii™	611714	FDA UDI	Class II	Unknown
Mini Ghost™	612694	FDA UDI	Class II	Unknown
Z-Med X™	618438	FDA UDI	Class II	Active
Tyshak X™	618341	FDA UDI	Class II	Active
Compass ™	613951	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.