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PENUMBRA, INC.

United States·US-MF-000008514

Last updated September 17, 2026

Information

Country: United States
Address: One Penumbra Place, Alameda, United States
Website: penumbrainc.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Mary Rose
EUDAMED SRN: US-MF-000008514
FDA FEI Number: 3013758550
DUNS Number: 191077671

Catalogue (1506)

Page 11 of 31

Device	Model / Reference	Registries	Class	Status
Ruby	RBY2C2060-B	FDA UDI	Class II	Active
Penumbra Coil 400	4004C0615-A	FDA UDI	Class II	Active
Indigo System	SEPC4	FDA UDI	Class II	Active
Penumbra System	PSC054L127-B	FDA UDI	Class II	Active
Benchmark	BMK6F95H1130	FDA UDI	Class II	Active
Indigo System	LITNG12HTORQ115-A	FDA UDI	Class II	Active
Pod	RBYPOD14-A	FDA UDI	Class II	Active
Penumbra Coil 400	4002C0620	FDA UDI	Class II	Active
RUBY Coil	RBY4C0208-B	FDA UDI	Class II	Active
Benchmark MAX System	BMX9680BER105-B	FDA UDI	Class II	Active
Indigo System	CAT8XTORQ115KIT-A	FDA UDI	Class II	Active
Penumbra System	5MAXJET7-A	FDA UDI	Class II	Active
ELEMENT Vascular Access System	ELMNT17F33-A	FDA UDI	Class II	Active
Penumbra Coil 400	4006U0506-A	FDA UDI	Class II	Active
Penumbra Coil 400	4002C0925-A	FDA UDI	Class II	Active
Penumbra Coil 400	4002C2457-A	FDA UDI	Class II	Active
Penumbra Coil 400	4006C0305	FDA UDI	Class II	Active
RUBY Coil	RBY2C0305-B	FDA UDI	Class II	Active
Penumbra Coil 400	4004C1545-A	FDA UDI	Class II	Active
Benchmark MAX System	BMX9680BER105-A	FDA UDI	Class II	Active
Indigo System	LITNG8XTORQ115-S	FDA UDI	Class II	Active
Penumbra System	5MAXACE068L115-A	FDA UDI	Class II	Active
Indigo System	CAT8STR85-R	FDA UDI	Class II	Active
Penumbra Coil 400	4002C0515	FDA UDI	Class II	Active
Penumbra Coil 400	4006U0404	FDA UDI	Class II	Active
Penumbra System	PSS032	FDA UDI	Class II	Active
Neuron	PNMD8F088704	FDA UDI	Class II	Active
Benchmark	BMK6F115M	FDA UDI	Class II	Active
Benchmark	BMK6F95MSIM120	FDA UDI	Class II	Active
Penumbra Coil 400	4004J14	FDA UDI	Class II	Active
Penumbra Coil 400	4006U0201-A	FDA UDI	Class II	Active
Benchmark MAX System	BMX96100MBER125-B	FDA UDI	Class II	Active
POD Packing	RBYPODJ35-A	FDA UDI	Class II	Active
RUBY Coil	RBY2C0825-B	FDA UDI	Class II	Active
Penumbra Coil 400	4006U0309	FDA UDI	Class II	Active
Ruby XL Coil System	RBYPODXL0510-A	FDA UDI	Class II	Active
Swift Coil System	400SWCCL306-A	FDA UDI	Class II	Active
Indigo System	IST2-A	FDA UDI	Class II	Active
Swift Coil System	400SWPC07-A	FDA UDI	Class II	Active
Indigo System	CAT8TORQ85-B	FDA UDI	Class II	Active
Penumbra System	3MAXCKIT-A	FDA UDI	Class II	Active
Penumbra System	5MAXACE064KIT-A	FDA UDI	Class II	Active
Penumbra System	IAPS2	EUDAMEDFDA UDI	Class II	Active
Penumbra Coil 400	4002C0515-A	FDA UDI	Class II	Active
Smart Coil	400SMTHXSFT0202	FDA UDI	Class II	Active
Penumbra System	5MAXJET7L127-B	FDA UDI	Class II	Active
Indigo System	LITNGFXT100H1-D	FDA UDI	Class II	Active
Red 43	RED43HFKIT138-A	FDA UDI	Class II	Active
Penumbra Coil 400	4002C1545-A	FDA UDI	Class II	Active
Smart Coil	400SMTXSFT4H20	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Penumbra Europe GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 15, 2020	Z-0848-2021	—	terminated	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Dec 15, 2020	Z-0851-2021	—	terminated	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Dec 15, 2020	Z-0850-2021	—	terminated	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Dec 15, 2020	Z-0849-2021	—	terminated	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
Jun 9, 2017	Z-2702-2017	—	terminated	Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.
Mar 4, 2011	Z-1906-2011	—	terminated	The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil.
Oct 25, 2010	Z-0428-2011	—	terminated	Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.
Sep 22, 2009	Z-0001-2010	—	terminated	Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient.
Jul 2, 2009	Z-2049-2009	—	terminated	Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.
Jul 1, 2009	Z-2313-2009	—	terminated	Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Penumbra Inc. Roseville, CA · US FEI 3016591327