Class 2 Device Recall QuickFlex, QuickFlex XL

• Date Initiated by Firm: April 03, 2012
• Date Posted: May 03, 2012
• Recall Status: Terminated on July 17, 2012
• Recall Number: Z-1483-2012
• Recall Event ID: 61656
• PMA Number: P030054S049
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - Product Code NIK
• Product: Cardiac Resynchronization Therapy (CRT) Leads; ; Trade Name: QuickFlex, QuickFlex XL; ; Model Numbers: QuickFlex and QuickFlex XL: model 1156T, model 1158T; ; Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead.
• Code Information: All lots
• Recalling Firm/ Manufacturer: St Jude Medical CRMD; 15900 Valley View Ct; Sylmar CA 91342-3577
• For Additional Information Contact: 818-362-6822
• Manufacturer Reason for Recall: Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
• FDA Determined Cause: Device Design
• Action: A recall communication was initiated on 4/3/12 with St. Jude Medical forwarding a Medical Device Advisory to all doctors who have received the St. Jude QuickSite and QuickFlex Left Ventricular CRT leads models 1056T, 1058T, 1156T, and 1158T. The letter provides the doctors with the problems identified and actions to be taken. Doctors with any questions or concerns are instructed to contact their local St. Jude Medical representative or their Technical Services Department at (800) 722-3774. A Physician Device Advisory Notice for the QuickSite and QuickFlex Left Ventricular CRT Leads was issued on 4/3/12 to physicians who have received the recalled products. The notice provides the physicians with the problem identified and actions to be taken. Physicians are instructed to return any packaged product in hospital inventory to SJM Sales Representatives. For implanted product, due to the nature of the issue, externalized conductors may be observed with no electrical or performance anomalies. Therefore, prophylactic explant is not recommended. It is recommended that physicians continue to monitor their patients' implanted system at regularly scheduled intervals. A Medical Advisory and Inventory Management Information letter was sent on 4/3/12 to hospital administrators to notify them of the problems identified and the actions to be taken.
• Quantity in Commerce: 101,000 units (59,000 units in US)
• Distribution: Worldwide Distribution -- Algeria, Argentina, Australia, Austria, Bahrain, Balkan, Baltic, Belarus, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Montenegro, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Paraguay, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Serbia Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, US, Venezuela, and Yemen.
• 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.

• PMA Database: PMAs with Product Code = NIK and Original Applicant = Abbott Medical