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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 15 of 34

Device	Model / Reference	Registries	Class	Status
Tyshak Ii®	611917	FDA UDI	Class II	Active
Mini Ghost™	612698	FDA UDI	Class II	Active
Tyshak Ii®	611529	FDA UDI	Class II	Active
Mini Ghost™	612519	FDA UDI	Class II	Active
COEfficient™	611211	FDA UDI	Class III	Active
Mullins X™	618815	FDA UDI	Class II	Active
CP Stent™	614367	FDA UDI	Class III	Active
Z-Med™	610486	FDA UDI	Class II	Active
Tyshak Ii®	611792	FDA UDI	Class II	Unknown
G-Armor Stent®	614737	FDA UDI	Class III	Active
Pts®	613702	FDA UDI	Class II	Active
CP Stent™	614559	FDA UDI	Class III	Active
CP Stent™	614343	FDA UDI	Class III	Active
Z-Med Ii™	611748	FDA UDI	Class II	Active
Tyshak Ii®	611557	FDA UDI	Class II	Active
CP Stent™	614346	FDA UDI	Class III	Active
Mullins X™	618808	FDA UDI	Class II	Active
Z-Med Ii X™	618712	FDA UDI	Class II	Active
Mini Ghost™	612581	FDA UDI	Class II	Unknown
Mini Ghost™	612591	FDA UDI	Class II	Active
Bib®	614423	FDA UDI	Class II	Active
Tyshak®	610626	FDA UDI	Class II	Unknown
Mini Ghost™	612710	FDA UDI	Class II	Unknown
G-Armor Stent®	614782	FDA UDI	Class III	Active
Tyshak®	610663	FDA UDI	Class II	Active
NuDEL	614579	FDA UDI	Class III	Active
CP Stent™	614487	FDA UDI	Class III	Active
Mini Ghost™	612575	FDA UDI	Class II	Active
Bib®	614416	FDA UDI	Class II	Active
Compass ™	613979	FDA UDI	Class II	Active
Elite HV®	612815	FDA UDI	Class II	Active
Tyshak®	610533	FDA UDI	Class II	Unknown
Z-Med Ii™	611732	FDA UDI	Class II	Active
Micro-Access Elite®	613353	FDA UDI	Class II	Unknown
CP Stent™	614366	FDA UDI	Class III	Active
Tyshak®	610550	FDA UDI	Class II	Active
Compass ™	613946	FDA UDI	Class II	Active
Z-Med™	610462	FDA UDI	Class II	Active
Micro-Access Elite®	613362	FDA UDI	Class II	Unknown
NuCLEUS-X™	612024	FDA UDI	Class II	Active
Seamless™	614713	FDA UDI	Class I	Active
CP Stent™	614477	FDA UDI	Class III	Active
Mini Ghost™	612757	FDA UDI	Class II	Unknown
Z-Med Ii X™	618716	FDA UDI	Class II	Active
Z-Med™	610238	FDA UDI	Class II	Active
CP Stent™	614313	FDA UDI	Class III	Active
Accel®	613930	FDA UDI	Class I	Active
Mini Ghost™	612511	FDA UDI	Class II	Active
Tyshak Ii®	611945	FDA UDI	Class II	Active
Z-Med Ii™	611769	FDA UDI	Class II	Active

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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.