Facility

PENUMBRA, INC.

3 recall(s) on record — most severe on record: Class I.

Key facts

3recalls · worst Class I

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005168196
Establishment type	Manufacture Medical Device
Location	One Penumbra Place Alameda, CA, US 94502
Registration status	Active · expires 2026
Parent company	PENUMBRA, INC. (owner-operator 9072336)
Brand names	Penumbra ACE System

Activity by year

Recalls (3)
Inspections (3)

Devices registered here (1)

Catheter, Thrombus Retriever
Product code NRY (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250

Recalls & enforcement

Class IIOngoing2026-06-03
Due to manufacturing issues, reperfusion catheters may fractures
Class ITerminated2020-12-15
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.
Class ITerminated2017-06-09
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.

FDA inspections (3)

NAI2021-06-21
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2017-02-13
No Action Indicated · Bioresearch Monitoring
NAI2016-02-23
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “PENUMBRA, INC. (FEI 3005168196) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005168196-penumbra-inc/

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