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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 9 of 34

Device	Model / Reference	Registries	Class	Status
G-Armor Stent®	614806	FDA UDI	Class III	Active
Tyshak®	610667	FDA UDI	Class II	Unknown
Z-Med™	611782	FDA UDI	Class II	Unknown
Tyshak®	610647	FDA UDI	Class II	Active
Z-Med X™	618445	FDA UDI	Class II	Active
Mini Ghost™	612744	FDA UDI	Class II	Active
Mini Ghost™	612574	FDA UDI	Class II	Active
Tyshak Ii®	611930	FDA UDI	Class II	Active
Accel®	613909	FDA UDI	Class II	Active
Z-Med™	611810	FDA UDI	Class II	Active
Pts-X™	613721	FDA UDI	Class II	Active
CP Stent™	614374	FDA UDI	Class III	Active
CP Stent™	614524	FDA UDI	Class III	Active
Mini Ghost™	612660	FDA UDI	Class II	Unknown
CP Stent™	614551	FDA UDI	Class III	Active
Accel®	612139	FDA UDI	Class I	Active
Tyshak X™	618338	FDA UDI	Class II	Active
Mullins X™	618802	FDA UDI	Class II	Active
Z-Med Ii™	611799	FDA UDI	Class II	Active
Pts®	613704	FDA UDI	Class II	Active
Mini Ghost™	612688	FDA UDI	Class II	Unknown
Mini Ghost™	612730	FDA UDI	Class II	Unknown
Impact™	202120A	FDA UDI	Class II	Active
CP Stent™	614535	FDA UDI	Class III	Active
Compass ™	613948	FDA UDI	Class II	Active
Tyshak Ii®	611937	FDA UDI	Class II	Active
CP Stent™	614540	FDA UDI	Class III	Active
Micro-Access Elite®	613369	FDA UDI	Class II	Unknown
B.braun	613400	FDA UDI	Class II	Unknown
Mini Ghost™	613857	FDA UDI	Class II	Active
CP Stent™	614303	FDA UDI	Class III	Active
NuDEL	614562	FDA UDI	Class III	Active
Celsite	5433823	FDA UDI	Class II	Active
Accel®	613936	FDA UDI	Class II	Active
COEfficient™	611221	FDA UDI	Class III	Active
Z-Med X™	618454	FDA UDI	Class II	Active
CP Stent™	614513	FDA UDI	Class III	Active
COEfficient™	611201	FDA UDI	Class III	Active
Z-Med™	611679	FDA UDI	Class II	Active
Mini Ghost™	612570	FDA UDI	Class II	Unknown
Pts-X™	613725	FDA UDI	Class II	Active
Bib®	614410	FDA UDI	Class II	Active
Accel®	613924	FDA UDI	Class II	Active
Accel®	613911	FDA UDI	Class II	Active
Tyshak Ii®	611913	FDA UDI	Class II	Active
Micro-Access Elite®	613356	FDA UDI	Class II	Unknown
Mini Ghost™	612724	FDA UDI	Class II	Unknown
Mini Ghost™	612703	FDA UDI	Class II	Unknown
Z-Med Ii™	611756	FDA UDI	Class II	Active
Tyshak X™	618345	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.