Facility

Penumbra Costa Rica, S.R.L.

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

Key facts

3recalls · worst Class I

—inspections in our data

—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)	3043869342
Establishment type	Manufacture Medical Device
Location	Zona Franca La Lima, Multitenant dos Guadalupe Cartago, CR 30106
Registration status	Active · expires 2026
Parent company	PENUMBRA, INC. (owner-operator 9072336)
Brand names	Penumbra Smart Coil

Activity by year

Recalls (3)

Devices registered here (2)

Device, Neurovascular Embolization
Product code HCG (opens in a new tab) · Class II · Neurology · 21 CFR 882.5950
Device, Vascular, For Promoting Embolization
Product code KRD (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.3300

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.

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 Costa Rica, S.R.L. (FEI 3043869342) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3043869342-penumbra-costa-rica-s-r-l/

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