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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 33 of 34

Device	Model / Reference	Registries	Class	Status
COEfficient™	611247	FDA UDI	Class III	Unknown
Tyshak Ii®	611532	FDA UDI	Class II	Active
Micro-Access Elite®	613374	FDA UDI	Class II	Unknown
Tyshak®	610527	FDA UDI	Class II	Active
Mini Ghost™	613816	FDA UDI	Class II	Unknown
TYSHAK Mini®	611993	FDA UDI	Class II	Active
NuDEL	614565	FDA UDI	Class III	Active
Z-Med Ii™	611715	FDA UDI	Class II	Active
NuDEL	614587	FDA UDI	Class III	Active
Tyshak®	610524	FDA UDI	Class II	Active
Bib®	614442	FDA UDI	Class II	Active
Z-Med™	610484	FDA UDI	Class II	Active
COEfficient™	611233	FDA UDI	Class III	Unknown
G-Armor Stent®	614798	FDA UDI	Class III	Active
Bib®	614389	FDA UDI	Class II	Active
Mini Ghost™	612746	FDA UDI	Class II	Unknown
Z-Med Ii™	611708	FDA UDI	Class II	Unknown
Tyshak Ii®	611932	FDA UDI	Class II	Active
Mini Ghost™	612735	FDA UDI	Class II	Unknown
TYSHAK NuCLEUS™	612076	FDA UDI	Class II	Active
Tyshak Ii®	611793	FDA UDI	Class II	Active
CP Stent™	614489	FDA UDI	Class III	Active
CP Stent™	614363	FDA UDI	Class III	Active
Tyshak®	610653	FDA UDI	Class II	Unknown
Tyshak®	610634	FDA UDI	Class II	Unknown
Z-Med™	610482	FDA UDI	Class II	Active
CP Stent™	614330	FDA UDI	Class III	Active
Mini Ghost™	613864	FDA UDI	Class II	Unknown
Z-Med X™	618400	FDA UDI	Class II	Unknown
Micro-Access Elite®	613370	FDA UDI	Class II	Unknown
Tyshak®	610547	FDA UDI	Class II	Active
Z-Med X™	618419	FDA UDI	Class II	Active
Mini Ghost™	612538	FDA UDI	Class II	Active
Z-Med™	612061	FDA UDI	Class II	Active
Z-Med Ii™	611004	FDA UDI	Class II	Active
Z-Med Ii X™	618714	FDA UDI	Class II	Unknown
COEfficient™	611220	FDA UDI	Class III	Active
Mini Ghost™	612727	FDA UDI	Class II	Unknown
Seamless™	614714	FDA UDI	Class I	Active
Mini Ghost™	612712	FDA UDI	Class II	Unknown
Z-Med Ii X™	618719	FDA UDI	Class II	Active
Z-Med Ii™	611722	FDA UDI	Class II	Active
Seamless™	614821	FDA UDI	Class I	Active
Mullins X™	618810	FDA UDI	Class II	Active
Z-Med Ii™	611750	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612077	FDA UDI	Class II	Unknown
Tyshak®	610649	FDA UDI	Class II	Active
CP Stent™	614508	FDA UDI	Class III	Active
Tyshak X™	618301	FDA UDI	Class II	Unknown
Mini Ghost™	612592	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.