Recall Z-0785-2019

Reason for recall

Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.

FDA-determined cause: Process control

Action taken

The firm, Medtronic, began notifying US consignees on 27-Nov-2018 via hand delivery to be followed up with a UPS 2-Day communication titled "URGENT MEDICAL DEVICE RECALL" to each listed consignee that does not confirm hand delivery. Communications OUS also began 27-Nov-2018 using locally approved methods. The letter described the product, problem and actions to be taken. Customers were requested to do the following: 1. Identify and quarantine all unused affected product as listed in your inventory. 2. Return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-854-3570 to initiate a product return. Your local Medtronic Representative can assist you in the return and replacement of this product as necessary. 3. Complete the enclosed Customer Confirmation Certificate and email to RS.CFQFCA@medtronic.com. If you have any questions about this action, please contact your Medtronic representative or call Director, Cardiac and Vascular Group, at 763-526-2513 or email: carlos.j.alfonzo@medtronic.com.