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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 11 of 34

Device	Model / Reference	Registries	Class	Status
Z-Med X™	618410	FDA UDI	Class II	Unknown
Z-Med Ii™	611719A	FDA UDI	Class II	Unknown
Impact™	204750	FDA UDI	Class II	Active
COEfficient™	611230	FDA UDI	Class III	Active
Pts-X™	613738	FDA UDI	Class II	Active
Multi-Track™	615006	FDA UDI	Class II	Active
NuDEL	614586	FDA UDI	Class III	Active
Mini Ghost™	612674	FDA UDI	Class II	Active
Impact™	124120	FDA UDI	Class II	Active
Tyshak X™	618308	FDA UDI	Class II	Unknown
COEfficient™	611239	FDA UDI	Class III	Unknown
G-Armor Stent®	614735	FDA UDI	Class III	Active
Bib®	614462	FDA UDI	Class II	Active
Tyshak X™	618318	FDA UDI	Class II	Unknown
Z-Med™	611820	FDA UDI	Class II	Active
Mini Ghost™	612586	FDA UDI	Class II	Unknown
SwitchBack™	622519	FDA UDI	Class II	Active
G-Armor Stent®	614740	FDA UDI	Class III	Active
Accel™	613214	FDA UDI	Class I	Active
Tyshak X™	618325	FDA UDI	Class II	Unknown
CP Stent™	614380	FDA UDI	Class III	Active
CP Stent™	614335	FDA UDI	Class III	Active
CP Stent™	614542	FDA UDI	Class III	Active
Tyshak®	610688	FDA UDI	Class II	Active
Compass ™	613953	FDA UDI	Class II	Active
Z-Med Ii™	611737	FDA UDI	Class II	Active
G-Armor Stent®	614792	FDA UDI	Class III	Active
CP Stent™	614306	FDA UDI	Class III	Active
Tyshak X™	618302	FDA UDI	Class II	Unknown
Bib®	614413	FDA UDI	Class II	Active
G-Armor Stent®	614817	FDA UDI	Class III	Active
G-Armor Stent®	614728	FDA UDI	Class III	Active
Tyshak Ii®	611781	FDA UDI	Class II	Active
NuCLEUS-X™	612031	FDA UDI	Class II	Active
Mini Ghost™	612687	FDA UDI	Class II	Unknown
Elite HV®	612816	FDA UDI	Class II	Active
Mini Ghost™	612766	FDA UDI	Class II	Active
Bib®	614628	FDA UDI	Class II	Active
CP Stent™	614387	FDA UDI	Class III	Active
Mini Ghost™	612529	FDA UDI	Class II	Active
Tyshak®	610677	FDA UDI	Class II	Unknown
CP Stent™	614314	FDA UDI	Class III	Active
Mini Ghost™	612696	FDA UDI	Class II	Unknown
COEfficient™	611689	FDA UDI	Class III	Active
Mini Ghost™	612700	FDA UDI	Class II	Unknown
B.braun	612134	FDA UDI	Class II	Active
Tyshak®	610657	FDA UDI	Class II	Unknown
Z-Med™	610473	FDA UDI	Class II	Unknown
Z-Med™	610496	FDA UDI	Class II	Active
G-Armor Stent®	614810	FDA UDI	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.