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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 18 of 34

Device	Model / Reference	Registries	Class	Status
Tyshak Ii®	611928	FDA UDI	Class II	Active
Mini Ghost™	612685	FDA UDI	Class II	Unknown
Z-Med X™	618408	FDA UDI	Class II	Unknown
Mini Ghost™	612673	FDA UDI	Class II	Unknown
Micro-Access Elite®	613360	FDA UDI	Class II	Unknown
Z-Med™	610452	FDA UDI	Class II	Unknown
Pts®	613700	FDA UDI	Class II	Active
Mini Ghost™	612655	FDA UDI	Class II	Unknown
COEfficient™	611245	FDA UDI	Class III	Unknown
Mini Ghost™	612749	FDA UDI	Class II	Unknown
Z-Med X™	618437	FDA UDI	Class II	Active
Tyshak Ii®	611530	FDA UDI	Class II	Active
Z-Med™	610458	FDA UDI	Class II	Active
CP Stent™	614486	FDA UDI	Class III	Active
G-Armor Stent®	614818	FDA UDI	Class III	Active
G-Armor Stent®	614729	FDA UDI	Class III	Active
Z-Med Ii™	611763	FDA UDI	Class II	Active
Compass ™	613958	FDA UDI	Class II	Active
Mini Ghost™	612764	FDA UDI	Class II	Unknown
Tyshak X™	618319	FDA UDI	Class II	Active
B.braun	613405	FDA UDI	Class II	Unknown
Z-Med™	610234	FDA UDI	Class II	Active
Tyshak X™	618346	FDA UDI	Class II	Active
G-Armor Stent®	614771	FDA UDI	Class III	Active
Mini Ghost™	613800	FDA UDI	Class II	Active
Z-Med Ii X™	618705	FDA UDI	Class II	Active
Accel®	613905	FDA UDI	Class II	Active
Tyshak X™	618314	FDA UDI	Class II	Active
Celsite	5437025	FDA UDI	Class II	Unknown
Tyshak®	610505	FDA UDI	Class II	Active
Accel®	613928	FDA UDI	Class I	Active
Z-Med™	610492	FDA UDI	Class II	Active
Micro-Access Elite®	613355	FDA UDI	Class II	Unknown
Mini Ghost™	612672	FDA UDI	Class II	Unknown
Z-Med™	611672	FDA UDI	Class II	Active
Z-Med Ii™	611703	FDA UDI	Class II	Unknown
Z-Med™	610488	FDA UDI	Class II	Active
Z-Med Ii™	611716	FDA UDI	Class II	Active
CP Stent™	614533	FDA UDI	Class III	Active
NuCLEUS-X™	612023	FDA UDI	Class II	Active
B.braun	613402	FDA UDI	Class II	Unknown
D'vill™	612846	FDA UDI	Class II	Active
Z-Med Ii™	611766	FDA UDI	Class II	Active
Bib®	614625	FDA UDI	Class II	Active
G-Armor Stent®	614755	FDA UDI	Class III	Active
G-Armor Stent®	614734	FDA UDI	Class III	Active
CP Stent™	614522	FDA UDI	Class III	Active
Tyshak®	611160	FDA UDI	Class II	Unknown
Tyshak®	610676	FDA UDI	Class II	Active
Z-Med Ii X™	618734	FDA UDI	Class II	Active

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.