FDA Device Intelligence
Home › Xvivo Perfusion AB › XVIVO Lung Disposables Kit

XVIVO Lung Disposables Kit

Xvivo Perfusion AB · Model 19035 · UDI-DI 07350069520142

PHO
0
510(k) clearances
8
Adverse events
1
Recalls
13
Facilities

Description

The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS™) for ex vivo reconditioning of donor lungs.

Recalls

DateFirmReason
2022-04-08XVIVO PERFUSION ABThe weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.