Facility

XVIVO PERFUSION, INC.

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

Key facts

1recalls · worst Class II

2inspections · 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)	3009736925
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	16080 Table Mountain Pkwy Ste 500 Golden, CO, US 80403
Registration status	Active · expires 2026
Parent company	XVIVO Perfusion AB (owner-operator 10029831)
Brand names	XPS; XVIVO Lung Cannula Set; XVIVO PGM; XVIVO Disposable Kit; STEEN Solution; XPS Disposable Lung Circuit; XVIVO Organ Chamber

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Product code PHO (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IITerminated2022-04-08
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

FDA inspections (2)

VAI2018-08-30
Voluntary Action Indicated · Bioresearch Monitoring · citations posted
VAI2018-05-03
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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. “XVIVO PERFUSION, INC. (FEI 3009736925) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009736925-xvivo-perfusion-inc/

Not open yet

Alerts for XVIVO PERFUSION, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.