Class 3 Device Recall LivaNova Sterile Disposable Connectors

• Date Initiated by Firm: November 18, 2019
• Create Date: July 17, 2020
• Recall Status: Terminated on August 19, 2021
• Recall Number: Z-2642-2020
• Recall Event ID: 85858
• 510(K)Number: K833322
• Product Classification: Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
• Product: LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
• Code Information: Item# EC2135S, Lot No. 1923900091
• Recalling Firm/ Manufacturer: LivaNova USA Inc.; 14401 W 65th Way; Arvada CO 80004-3503
• For Additional Information Contact: 303-467-6306
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Packaging process control
• Action: 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.
• Quantity in Commerce: 140 units
• Distribution: Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DTL