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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 8 of 34

Device	Model / Reference	Registries	Class	Status
CP Stent™	614472	FDA UDI	Class III	Active
G-Armor Stent®	614785	FDA UDI	Class III	Active
Pts-X™	613719	FDA UDI	Class II	Active
G-Armor Stent®	614719	FDA UDI	Class III	Active
G-Armor Stent®	614753	FDA UDI	Class III	Active
COEfficient™	611217	FDA UDI	Class III	Active
Tyshak®	610516	FDA UDI	Class II	Active
Tyshak®	610538	FDA UDI	Class II	Active
Z-Med Ii™	611746	FDA UDI	Class II	Active
Z-Med™	610497	FDA UDI	Class II	Active
CP Stent™	614318	FDA UDI	Class III	Active
Pts-X™	613750	FDA UDI	Class II	Unknown
Tyshak®	610689	FDA UDI	Class II	Unknown
Mullins X™	618804	FDA UDI	Class II	Active
Bib®	614408	FDA UDI	Class II	Active
CP Stent™	614316	FDA UDI	Class III	Active
Pts-X™	613716	FDA UDI	Class II	Active
Pts-X™	613736	FDA UDI	Class II	Active
Z-Med X™	618453	FDA UDI	Class II	Active
Z-Med Ii X™	618751	FDA UDI	Class II	Active
CP Stent™	614558	FDA UDI	Class III	Active
Celsite	5433556	FDA UDI	Class II	Active
Bib®	614635	FDA UDI	Class II	Active
Z-Med Ii™	611800	FDA UDI	Class II	Active
Tyshak®	610503	FDA UDI	Class II	Unknown
Z-Med™	611565	FDA UDI	Class II	Active
Mini Ghost™	612589	FDA UDI	Class II	Unknown
Mini Ghost™	613865	FDA UDI	Class II	Active
Z-Med Ii™	611757	FDA UDI	Class II	Active
Compass ™	613954	FDA UDI	Class II	Active
CP Stent™	614336	FDA UDI	Class III	Active
Bib®	614455	FDA UDI	Class II	Active
COEfficient™	611692	FDA UDI	Class III	Active
COEfficient™	611202	FDA UDI	Class III	Active
Solace™	622517	FDA UDI	Class II	Active
Multi-Snare®	612973	FDA UDI	Class II	Unknown
Bib®	614414	FDA UDI	Class II	Active
Z-Med X™	618435	FDA UDI	Class II	Active
G-Armor Stent®	614725	FDA UDI	Class III	Active
CP Stent™	614521	FDA UDI	Class III	Active
Mini Ghost™	612693	FDA UDI	Class II	Active
Asept	622284	FDA UDI	Class II	Active
Elite HV®	612903	FDA UDI	Class II	Active
CP Stent™	614385	FDA UDI	Class III	Active
Elite HV®	612803	FDA UDI	Class II	Active
CP Stent™	614515	FDA UDI	Class III	Active
Bib®	614394	FDA UDI	Class II	Active
Z-Med™	611650	FDA UDI	Class II	Active
CP Stent™	614527	FDA UDI	Class III	Active
Multi-Track™	615007	FDA UDI	Class II	Unknown

Related Companies

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.