Class 2 Device Recall

• Date Initiated by Firm: September 02, 2005
• Date Posted: November 02, 2005
• Recall Status: Terminated on January 17, 2011
• Recall Number: Z-0117-06
• Recall Event ID: 33327
• 510(K)Number: K012274
• Product Classification: Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
• Product: standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.
• Code Information: Standard Hard Paddles part number: 3006228-013 and below
• Recalling Firm/ Manufacturer: Medtronic Emergency Response Systems, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: John A. Parks; 425-867-4681
• Manufacturer Reason for Recall: Potential for voltage pins in connector of therapy cable to break.
• FDA Determined Cause: Other
• Action: On 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing,
• Distribution: Devices were distributed worldwide.
• 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 = LDD and Original Applicant = MEDTRONIC PHYSIO-CONTROL CORP.