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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 6 of 34

Device	Model / Reference	Registries	Class	Status
Accel™	470192	FDA UDI	Class II	Active
Mini Ghost™	612670	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612080	FDA UDI	Class II	Unknown
Bib®	614452	FDA UDI	Class II	Active
Mini Ghost™	612662	FDA UDI	Class II	Unknown
Impact™	182120	FDA UDI	Class II	Unknown
CP Stent™	614386	FDA UDI	Class III	Active
G-Armor Stent®	614757	FDA UDI	Class III	Active
Z-Med Ii™	611745	FDA UDI	Class II	Active
Z-Med™	611555	FDA UDI	Class II	Active
Z-Med™	610485	FDA UDI	Class II	Active
CP Stent™	614476	FDA UDI	Class III	Active
NuDEL	614578	FDA UDI	Class III	Active
Accel®	612140	FDA UDI	Class II	Active
CP Stent™	614509	FDA UDI	Class III	Active
Tyshak Ii®	611929	FDA UDI	Class II	Active
Mini Ghost™	612657	FDA UDI	Class II	Active
Z-Med™	611808	FDA UDI	Class II	Active
Mini Ghost™	612571	FDA UDI	Class II	Unknown
Impact™	202750	FDA UDI	Class II	Active
COEfficient™	611225	FDA UDI	Class III	Active
Accel®	612137	FDA UDI	Class II	Active
Z-Med™	610451	FDA UDI	Class II	Unknown
Bib®	614467	FDA UDI	Class II	Active
Z-Med™	610481	FDA UDI	Class II	Active
Z-Med™	611784	FDA UDI	Class II	Active
Mini Ghost™	612741	FDA UDI	Class II	Unknown
Z-6™	611050	FDA UDI	Class II	Active
Micro-Access Elite®	613346	FDA UDI	Class II	Unknown
CP Stent™	614371	FDA UDI	Class III	Active
Mini Ghost™	612599	FDA UDI	Class II	Unknown
G-Armor Stent®	614800	FDA UDI	Class III	Active
CP Stent™	614529	FDA UDI	Class III	Active
SwitchBack™	622520	FDA UDI	Class II	Active
NuCLEUS-X™	612040	FDA UDI	Class II	Active
Z-Med X™	618423	FDA UDI	Class II	Active
COEfficient™	611234	FDA UDI	Class III	Unknown
CP Stent™	614497	FDA UDI	Class III	Active
Pts-X™	613722	FDA UDI	Class II	Active
Mini Ghost™	612751	FDA UDI	Class II	Unknown
Z-Med Ii™	611661	FDA UDI	Class II	Active
Mini Ghost™	612668	FDA UDI	Class II	Unknown
Z-Med™	610480	FDA UDI	Class II	Active
Tyshak®	611148	FDA UDI	Class II	Unknown
COEfficient™	611223	FDA UDI	Class III	Active
Mini Ghost™	612721	FDA UDI	Class II	Active
Z-Med™	610489	FDA UDI	Class II	Active
Bib®	614417	FDA UDI	Class II	Active
Tyshak Ii®	611942	FDA UDI	Class II	Active
Z-Med Ii™	611723	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.