Class 2 Device Recall Power cord used on BioConsole, autoLog, Sequestra

• Date Initiated by Firm: April 21, 2010
• Date Posted: June 30, 2010
• Recall Status: Terminated on December 24, 2011
• Recall Number: Z-1939-2010
• Recall Event ID: 55749
• 510(K)Number: K051303 K941921 K972894
• Product Classification: power cord on cardiopulmonary bypass - Product Code DWA
• Product: Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: Medtronic Bio-Console 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180. Medtronic Bio-Console 560 centrifugal pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. Medtronic autoLog, Model # ATLG110, Catalogue # ATLG110, ATLG110E ATLG110R. Medtronic Sequestra 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R.
• Code Information: Part # 66319 & 055476
• FEI Number: 1000116158
• Recalling Firm/ Manufacturer: Medtronic Cardiovascular Revascularization & Surgical Therap; 7611 Northland Dr N; Brooklyn Park MN 55428-1088
• For Additional Information Contact: 763-391-9000
• Manufacturer Reason for Recall: The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. This Field Notificatio
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were sent on 4/21/10 a Medtronic "Urgent Medical Device Recall Notice" letter dated April 19, 2010. The letter was addressed to their customers and described the problem and the product involved. They recommended to discontinue use of the AC power cords and to destroy them. Requested consignees to fill out the attached Medtronic Recall Certificate (FCA 1005), and return it to Medtronics.
• Quantity in Commerce: 619 USA, 80 OUS
• Distribution: Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.
• 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 = DWA; 510(K)s with Product Code = DWA; 510(K)s with Product Code = DWA