Facility

Cerenovus, Inc.

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

Key facts

1recalls · 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)	3007628272
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	6303 Waterford District Drive Miami, FL, US 33126
Registration status	Active · expires 2026
Parent company	Cerenovus, Inc. (owner-operator 9026915)
Brand names	ENVOY Distal Access (DA) Guiding Catheter; ENVOY (DA) Distal Access Guiding Catheter; ENVOY DA Guiding Catheter

Activity by year

Recalls (1)

Devices registered here (1)

Catheter, Percutaneous
Product code DQY (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250

Recalls & enforcement

Class IOngoing2025-10-02
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.

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. “Cerenovus, Inc. (FEI 3007628272) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007628272-cerenovus-inc/

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