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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 31 of 34

Device	Model / Reference	Registries	Class	Status
CP Stent™	614485	FDA UDI	Class III	Active
Pts-X™	613732	FDA UDI	Class II	Active
Mini Ghost™	612585	FDA UDI	Class II	Unknown
Mini Ghost™	612579	FDA UDI	Class II	Active
Bib®	614390	FDA UDI	Class II	Active
CP Stent™	614379	FDA UDI	Class III	Active
Mini Ghost™	612739	FDA UDI	Class II	Unknown
COEfficient™	611243	FDA UDI	Class III	Unknown
Z-Med Ii™	611701	FDA UDI	Class II	Active
Bib®	614436	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612069	FDA UDI	Class II	Active
Tyshak X™	618343	FDA UDI	Class II	Active
G-Armor Stent®	614742	FDA UDI	Class III	Active
Mini Ghost™	612593	FDA UDI	Class II	Unknown
Tyshak Ii®	611918	FDA UDI	Class II	Active
G-Armor Stent®	614738	FDA UDI	Class III	Active
Tyshak®	610534	FDA UDI	Class II	Active
Z-Med Ii™	611741	FDA UDI	Class II	Active
Mullins X™	618801	FDA UDI	Class II	Active
Mini Ghost™	612517	FDA UDI	Class II	Active
Accel®	613932	FDA UDI	Class I	Active
Z-Med X™	618447	FDA UDI	Class II	Active
COEfficient™	611238	FDA UDI	Class III	Unknown
Elite HV®	612800	FDA UDI	Class II	Active
COEfficient™	611246	FDA UDI	Class III	Active
CP Stent™	614507	FDA UDI	Class III	Active
D'vill™	612840	FDA UDI	Class II	Unknown
CP Stent™	614473	FDA UDI	Class III	Active
Tyshak®	611528	FDA UDI	Class II	Unknown
Tyshak X™	618303	FDA UDI	Class II	Unknown
G-Armor Stent®	614748	FDA UDI	Class III	Active
Compass ™	613963	FDA UDI	Class II	Active
Multi-Snare®	612974	FDA UDI	Class II	Unknown
Bib®	614631	FDA UDI	Class II	Active
Tyshak®	610661	FDA UDI	Class II	Unknown
Bib®	614412	FDA UDI	Class II	Active
COEfficient™	611207	FDA UDI	Class III	Active
Mini Ghost™	612653	FDA UDI	Class II	Active
Tyshak®	610678	FDA UDI	Class II	Unknown
G-Armor Stent®	614770	FDA UDI	Class III	Active
Bib®	614439	FDA UDI	Class II	Active
Z-Med Ii™	618725	FDA UDI	Class II	Active
Bib®	614395	FDA UDI	Class II	Active
Tyshak X™	618322	FDA UDI	Class II	Unknown
Z-Med X™	618422	FDA UDI	Class II	Active
D'vill™	612843	FDA UDI	Class II	Unknown
Tyshak®	610601A	FDA UDI	Class II	Active
Z-Med™	611686	FDA UDI	Class II	Active
Z-Med Ii™	611725	FDA UDI	Class II	Active
Pts-X™	613718	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.