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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 13 of 34

Device	Model / Reference	Registries	Class	Status
Z-Med™	611687	FDA UDI	Class II	Active
Multi-Track™	615004	FDA UDI	Class II	Unknown
Compass ™	613973	FDA UDI	Class II	Active
Mini Ghost™	612765	FDA UDI	Class II	Unknown
Accel®	613919	FDA UDI	Class II	Active
Mini Ghost™	612679	FDA UDI	Class II	Unknown
Tyshak®	610664	FDA UDI	Class II	Unknown
G-Armor Stent®	614744	FDA UDI	Class III	Active
Tyshak Ii®	611535	FDA UDI	Class II	Active
CP Stent™	614483	FDA UDI	Class III	Active
Compass ™	613945	FDA UDI	Class II	Active
Tyshak®	611158	FDA UDI	Class II	Unknown
G-Armor Stent®	614749	FDA UDI	Class III	Active
CP Stent™	614331	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612062	FDA UDI	Class II	Active
Impact™	164750	FDA UDI	Class II	Active
Tyshak X™	618309	FDA UDI	Class II	Unknown
Z-Med X™	618403	FDA UDI	Class II	Unknown
Tyshak®	610555	FDA UDI	Class II	Unknown
Tyshak®	610568	FDA UDI	Class II	Unknown
G-Armor Stent®	614809	FDA UDI	Class III	Active
Mullins X™	618829	FDA UDI	Class II	Active
CP Stent™	614326	FDA UDI	Class III	Active
Bib®	614450	FDA UDI	Class II	Active
G-Armor Stent®	614805	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612088	FDA UDI	Class II	Active
Z-Med Ii™	611743	FDA UDI	Class II	Active
COEfficient™	611237	FDA UDI	Class III	Unknown
Mini Ghost™	612504	FDA UDI	Class II	Unknown
Mini Ghost™	612535	FDA UDI	Class II	Active
TYSHAK Mini®	611988	FDA UDI	Class II	Active
Z-Med Ii™	611717	FDA UDI	Class II	Active
CP Stent™	614549	FDA UDI	Class III	Active
Tyshak Ii®	611950	FDA UDI	Class II	Active
Mini Ghost™	612736	FDA UDI	Class II	Active
Mini Ghost™	612513	FDA UDI	Class II	Unknown
Mini Ghost™	612555	FDA UDI	Class II	Unknown
Tyshak®	610658	FDA UDI	Class II	Unknown
CP Stent™	614376	FDA UDI	Class III	Active
Tyshak®	610554	FDA UDI	Class II	Unknown
Micro-Access Elite®	613368	FDA UDI	Class II	Unknown
CP Stent™	614310	FDA UDI	Class III	Active
CP Stent™	614491	FDA UDI	Class III	Active
Mini Ghost™	612753	FDA UDI	Class II	Unknown
Z-Med Ii™	611721	FDA UDI	Class II	Active
Z-Med Ii™	611700	FDA UDI	Class II	Active
Mini Ghost™	612678	FDA UDI	Class II	Active
Tyshak®	610627	FDA UDI	Class II	Unknown
Mini Ghost™	612500	FDA UDI	Class II	Unknown
Mini Ghost™	612747	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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.