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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 31 of 31

Device	Model / Reference	Registries	Class	Status
Ruby Extra Soft, 2mm x 1 cm	RBY6C0201	EUDAMEDFDA UDI	Class III	Active
Neuron Delivery Catheter (115cm/12cm)	PND6F11512	EUDAMEDFDA UDI	Class III	Active
Penumbra ENGINE Canister – Penumbra System	PAPS3	EUDAMEDFDA UDI	Class I	Active
Coil 400 Complex Standard, 7mm x 20 cm	4002C0720	EUDAMED	Class III	Active
4MAX DDC - Distal Delivery Catheter, 130 cm	4MAXDDC130	EUDAMEDFDA UDI	Class III	Active
Aspiration Catheter 3	CAT3	EUDAMEDFDA UDI	Class III	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