Class 2 Device Recall Pioneer Plus Catheter PPlus 120

• Date Initiated by Firm: April 30, 2010
• Date Posted: January 06, 2011
• Recall Status: Terminated on January 06, 2011
• Recall Number: Z-0864-2011
• Recall Event ID: 55541
• 510(K)Number: K081804
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculature over a standard length, commercially available 0.014" (0.36 mm) Rapid Exchange (RX) tracking guide wire. It utilizes an extendable, hollow Nitinol guide tip (needle) to facilitate the redirection and placement of a 0.014 (0.36 mm) Over the Wire (OTW) guide wire into peripheral vessels. Specification Developer: Medtronic, Minneapolis, MN. Manufactured by: Accellent, Laconia NH The Pioneer Plus Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus Catheter also provides an intra-luminal cross-sectional ultrasound image of the area of interest to facilitate placement of guide wires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature.
• Code Information: All Lots, no serial numbers.
• FEI Number: 3001452571
• Recalling Firm/ Manufacturer: Medtronic CardioVascular; 3576 Unocal Pl; Santa Rosa CA 95403
• For Additional Information Contact: 707-566-1548
• Manufacturer Reason for Recall: Needles may fail to retract and thus cause injury.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Medtronic sent an Urgent Medical Device Safety Information letter to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Sales Representatives were to contact each account and complete an acknowledgement form indicating the Physicians had been notified. For questions regarding this recall customers were to contact their local representative.
• Quantity in Commerce: 1,080 units
• Distribution: Worldwide Distribution - USA, Germany, Netherlands, Slovakia, and Spain
• 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 = DQY