Facility

XVIVO PERFUSION, INC.

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

Key facts

1recalls · worst Class II

—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)	3028907862
Establishment type	Manufacture Medical Device
Location	3250 Quentin Street, Suite #134 Aurora, CO, US 80011
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)

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.

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 3028907862) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3028907862-xvivo-perfusion-inc/

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