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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 25 of 34

Device	Model / Reference	Registries	Class	Status
Accel®	612130	FDA UDI	Class I	Active
Mini Ghost™	612667	FDA UDI	Class II	Unknown
Z-Med Ii™	611742	FDA UDI	Class II	Active
Tyshak Ii®	611923	FDA UDI	Class II	Active
Z-Med™	611813	FDA UDI	Class II	Active
Z-Med Ii™	611771	FDA UDI	Class II	Active
Accel®	612132	FDA UDI	Class I	Active
Bib®	614461	FDA UDI	Class II	Active
Accel®	613938	FDA UDI	Class I	Active
Z-Med™	611651	FDA UDI	Class II	Active
Mini Ghost™	612545	FDA UDI	Class II	Active
Bib®	614459	FDA UDI	Class II	Active
CP Stent™	614320	FDA UDI	Class III	Active
Accel®	613937	FDA UDI	Class I	Active
G-Armor Stent®	614736	FDA UDI	Class III	Active
Micro-Access Elite®	613357	FDA UDI	Class II	Unknown
Micro-Access Elite®	613347	FDA UDI	Class II	Unknown
Z-Med™	610478	FDA UDI	Class II	Active
Multi-Snare®	612971	FDA UDI	Class II	Unknown
Tyshak®	610668	FDA UDI	Class II	Unknown
Tyshak X™	618347	FDA UDI	Class II	Active
CP Stent™	614337	FDA UDI	Class III	Active
Z-Med Ii X™	618727	FDA UDI	Class II	Active
COEfficient™	611231	FDA UDI	Class III	Active
CP Stent™	614482	FDA UDI	Class III	Active
Tyshak X™	618323	FDA UDI	Class II	Unknown
Accel™	613210	FDA UDI	Class I	Active
COEfficient™	611214	FDA UDI	Class III	Active
Z-Med X™	618429	FDA UDI	Class II	Active
CP Stent™	614325	FDA UDI	Class III	Active
Elite HV®	612804	FDA UDI	Class II	Active
Mini Ghost™	612520	FDA UDI	Class II	Active
Tyshak®	610651	FDA UDI	Class II	Unknown
Z-Med X™	618424	FDA UDI	Class II	Active
G-Armor Stent®	614789	FDA UDI	Class III	Active
Mini Ghost™	612691	FDA UDI	Class II	Unknown
Bib®	614453	FDA UDI	Class II	Active
Z-Med™	611817	FDA UDI	Class II	Active
Pts-X™	613744	FDA UDI	Class II	Active
Z-Med™	611821	FDA UDI	Class II	Active
Impact™	182750	FDA UDI	Class II	Active
Mini Ghost™	612748	FDA UDI	Class II	Unknown
Mini Ghost™	612731	FDA UDI	Class II	Unknown
Tyshak®	610682	FDA UDI	Class II	Unknown
COEfficient™	611203	FDA UDI	Class III	Active
Tyshak Ii®	611780	FDA UDI	Class II	Active
Z-Med X™	618442	FDA UDI	Class II	Active
Tyshak Ii®	611796	FDA UDI	Class II	Active
Celsite	5437026	FDA UDI	Class II	Unknown
Z-Med™	611815	FDA UDI	Class II	Active

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.