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U.S. Department of Health and Human Services

Class 2 Device Recall Pioneer Plus Catheter PPlus 120

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  Class 2 Device Recall Pioneer Plus Catheter PPlus 120 see related information
Date Initiated by Firm April 30, 2010
Date Posted January 06, 2011
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = MEDTRONIC INC.
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