XVIVO Organ Chamber REF 19020 recallZ-1212-2022 · Xvivo Perfusion AB · initiated Apr 8, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Xvivo Perfusion AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
FDA root cause category: Under Investigation by firm
What the company is doing
On or about 04/11/2022, XVIVO Inc. issued an "URGENT- Field Safety Notice" for its XVIVO Organ Chamber via email to customers informing them XVIVO has identified that the primary package for a number of batches may have notable defects in the weld of the bag. The notable defects are unsealed sections of the weld (i.e. the bag is not completely closed). Unsealed sections in the weld may compromise the sterility of the product and therefore it is important to NOT use a product showing this defect. Customer are instructed to: 1. Carefully check the primary package for unsealed sections. A follow-up "URGENT:-Medical Device Correction" issued on or about 05/06/2022, this letter provides photos of example of unsealed welds. 2. If unsealed sections are noted, do not use the product and contact XVIVO Customer Support at [email protected] for further action. 3. if not defects are noted, the product may be used as intended. Any questions or additional information, contact Customer Support at [email protected] or telephone number +1-303-395-9171.
Recall details
- Recall number
- Z-1212-2022
- Status
- Terminated
- Initiated by the company
- Apr 8, 2022
- Recalling firm
- Xvivo Perfusion AB
- Quantity
- 80 devices
- Product code
- PHO
- FDA submissions
- P180014
- Distribution
- U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
Product description
XVIVO Organ Chamber REF 19020
Code information (models, lots, serial numbers)
Model Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- XVIVO Organ Chamber™ 19020Xvivo Perfusion AB · Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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