XVIVO Organ Chamber™ 19020Recalls & reported problems

Xvivo Perfusion AB · The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient. · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07350069520074), received between Apr 19, 2022 and Apr 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Apr 8, 2022Class IITerminated
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Z-1212-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Unsealed Device Packaging1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 19, 2022Unsealed Device Packaging; Unsealed Device Packaging
MALFUNCTION ACCORDING TO THE REPORTER THREE DEVICES WITH UNSEALED STERILE BARRIER WERE FOUND AT USER FACILITY QUALITY INSPECTION WHEN RECEIVING THE GOODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14140108 ↗

Device details

UDI-DI	`07350069520074`
Brand	XVIVO Organ Chamber™
Model	19020
Company	Xvivo Perfusion AB
Product code	PHO · Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 22, 2021

Device type (GMDN): Lung donor-organ preservation/evaluation system lung-interface set

A collection of disposable devices intended to be used with a lung donor-organ preservation/evaluation system to house, supply oxygen to, and/or manage preservation solution for, the preserved lung(s). It typically consists of the following components: a lung chamber, breathing circuit tubing, a configuration of fluid delivery tubing, a fluid reservoir, oxygenator components, filter(s), sensors, and may also include surgical drapes. This is a single-use device.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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