FDA MedWatch – GENOSYL DS; Nitric Oxide Delivery System by Vero Biotech:

TOPIC: GENOSYL DS; Nitric Oxide Delivery System by Vero Biotech: Class I Recall – Due to Software Error

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: Vero Biotech is recalling its GENOSYL DS; Nitric Oxide Delivery System due to a software issue that leads to errors in the delivery of nitric oxide. Typically, this issue caused delivery of lower-than-expected dosage of nitric oxide during the transition between primary and backup console. If this happens, this could cause serious adverse events such as drops in oxygen level, heart problems, and clinical instability in the newborn.

There have been 11 complaints, three injuries and no deaths reported for this issue.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The GENOSYL DS; Nitric Oxide Delivery System is used to deliver a constant flow of GENOSYL (Nitric Oxide), which is a drug to help open blood vessels and improve oxygen levels in critically ill newborns with respiratory failure. 

RECOMMENDATION: On Jun 15, 2021, Vero Biotech sent an “Urgent: Medical Device Correction” letter to customers stating the release of Software 2.2.4 will correct the adverse events associated with Software 2.2.3. The letter also gave the following instructions:

• The firm began traveling to consignee sites and repairing consoles on April 7, 2021. Contact the firm if you are unsure whether they have updated your devices’ software.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.