LivaNova USA Inc. LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.

Recommended Action

Per FDA guidance

Affected customers were contacted by letter sent via email or by phone call on November 18th, 2019. Customers were informed that a single lot of LivaNova USA Sterile Disposable Connector item# EC2135S, lot number 1923900091, contained a 3/8 x 1/4 reducer instead of the specified 1/2 x 1/2 connector. Customers were requested to check their inventory, quarantine (and do not use) any affected devices, complete the Customer Response Form and submit the completed form by email to USFSN@livanova.com to confirm quantity of affected products in the facility. Customers were informed that affected product should be returned to LivaNova, and that their LivaNova reference person would contact customers to organize the replacement of the affected products. Customers were informed that no patient injuries have been reported and that the event is unlikely to cause any harm to the patient or user. Customers were requested to ensure that this Medical Device Correction notice is communicated to all personnel within their organization who need to be aware of it, and, if a customer has transferred any of the affected devices to a third party, to please communicate this information to them and inform the LivaNova Quality Assurance Team at USFSN@livanova.com. Customers with questions may contact LivaNova at (800) 986-4702 or by e-mail to USFSN@livanova.com. Customers were informed that this action is being reported to the Food and Drug Administration (FDA). Adverse reactions or quality problems experienced with the use of this product may be reported to LivaNova at customerquality@livanova.com or the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Distribution

As reported by FDA

IN, KS, MN, MO, UT, WA