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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 28 of 31

Device	Model / Reference	Registries	Class	Status
Indigo System	IST4-A	FDA UDI	Class II	Active
Indigo System	CAT12HTORQ85KIT	FDA UDI	Class II	Active
RUBY Coil	RBY4C0315-A	FDA UDI	Class II	Active
RUBY Coil	RBY4C0204-A	FDA UDI	Class II	Active
Smart Coil	400SMTXSFT3H06	FDA UDI	Class II	Active
LP Coil System	RLPH1	EUDAMEDFDA UDI	Class II	Active
Penumbra Coil 400	4002C0935-A	FDA UDI	Class II	Active
Indigo System	LITNG12XTORQ115-A	FDA UDI	Class II	Active
LP Coil System	RBYLP0204	FDA UDI	Class II	Active
RUBY Coil	RBY2C0535-B	FDA UDI	Class II	Active
RUBY Coil	RBY2C0305-A	FDA UDI	Class II	Active
Smart Coil	400SMTSFT0408	FDA UDI	Class II	Active
Smart Coil	400SMTSTD0835	FDA UDI	Class II	Active
Smart Coil	400SMTSFT0710	FDA UDI	Class II	Active
Penumbra Coil 400	4002C0506-A	FDA UDI	Class II	Active
Penumbra Coil 400	4004C1645	FDA UDI	Class II	Active
RUBY Coil	RBY2C0740-A	FDA UDI	Class II	Active
Smart Coil	400SMTXSFT3H15	FDA UDI	Class II	Active
Benchmark	BMK6F105BER130	FDA UDI	Class II	Active
Indigo System	CAT8XTORQ115-S	FDA UDI	Class II	Active
Indigo System	CAT12HTORQ115KIT-A	FDA UDI	Class II	Active
Swift Coil System	400SWCCL410-A	FDA UDI	Class II	Active
Smart Coil	400SMTSTD0510	FDA UDI	Class II	Active
LP Coil System	RBYLP0860-B	FDA UDI	Class II	Active
Indigo System	CAT8STR85KIT-T	FDA UDI	Class II	Active
Smart Coil	400SMTSFT2H05	FDA UDI	Class II	Active
Benchmark MAX System	BMX96100SIM125-B	FDA UDI	Class II	Active
Swift Coil System	400SWCCL204-A	FDA UDI	Class II	Active
Penumbra Coil 400	4004C1440-A	FDA UDI	Class II	Active
Indigo System	SEP12-A	FDA UDI	Class II	Active
Penumbra Coil 400	4006C0418	FDA UDI	Class II	Active
Apollo System	APG1-A	FDA UDI	Class II	Active
Smart Coil	400SMTSFT2H06	FDA UDI	Class II	Active
Neuron	PNML6F0881004R	FDA UDI	Class II	Active
Indigo System	LITNGFHT115BER-A	FDA UDI	Class II	Active
Penumbra Coil 400	4002C0630	FDA UDI	Class II	Active
Penumbra Coil 400	4006U0630-A	FDA UDI	Class II	Active
Apollo System	APIV1-A	FDA UDI	Class II	Active
Smart Coil	400SMTSFT0720	FDA UDI	Class II	Active
Penumbra Coil 400	4006C0508-A	FDA UDI	Class II	Active
REAL Sensor Bands	BND	FDA UDI	Class II	Active
PX SLIM Delivery Microcatheter	PXSLIMSTR-B	FDA UDI	Class II	Active
Lantern Delivery Catheter	PXSLIMLAN115STR	FDA UDI	Class II	Active
Ruby XL Coil System	RBYPODXL1055-A	FDA UDI	Class II	Active
Lantern Delivery Catheter	PXSLIMLAN115T45	FDA UDI	Class II	Active
Benchmark MAX System	BMX7F105MBER130-A	FDA UDI	Class II	Active
Systems Configuration	ACE603DVELSYS-A	FDA UDI	Class II	Active
Ruby XL Coil System	RBYXL4055-A	FDA UDI	Class II	Active
Velocity Delivery Microcatheter	VEL160STR-A	FDA UDI	Class II	Active
Swift Coil System	400SWPC25-A	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