Class 2 Device Recall Medtronic FlexCath 3FC12

• Date Initiated by Firm: July 15, 2011
• Date Posted: September 12, 2011
• Recall Status: Terminated on June 07, 2012
• Recall Number: Z-3186-2011
• Recall Event ID: 59477
• 510(K)Number: K102176
• Product Classification: Catheter, steerable - Product Code DRA
• Product: Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. Rx only. Sterilized using ethylene oxide. Manufacturer: Medtronic CryoCath LP, Kirkland, Quebec H9H 5H3, Canada. Product Usage: The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
• Code Information: 15440, 15441, 15438, 15439, 62503, 97317, 97313, 62504 14180, 53903, 14191, 14182, 93588, 93590, 93593 46732, 46733, 50665, 89982, 89988, 53902, 53900 06055, 16889, 16890, 16891, 20820, 26063, 26065, 26066, 91369 06044, 06045, 06046, 06047, 06049, 06048, 06050, 06052, 06051, 06053, 06054 05825, 05826, 05892, 05893, 05894, 05924, 05925, 05926, 05941, 05942, 05943 05650, 05651, 05652 05483, 05484, 05537, 05538 05371, 05372, 05398, 05399, 05482 05270, 05271, 05353, 05272, 05354, 05355, 05370 05127, 05128, 05171, 05172, 05225, 05226, 05267, 05268, 05269 04985, 04986, 05036, 05037, 05038 97318, 37267, 85114, 90801, 90782, 90778, 37266, 37264, 37229 85820, 09623, 85818, 85819, 85814, 09624, 09625, 09627, 09626, 00721, 00722, 96490 23512, 00724, 23511, 23697, 23698, 00723, 35329, 35328, 35332, 35331, 38075, 38074, 35334, 61553, 61555, 61554 96439, 61556, 61557, 94235, 94240, 94238, 94233, 26365, 26375, 26378 26382, 26385, 26384, 36902, 36905, 36909, 36911, 51097, 26374, 71318 71318, 51121, 36906, 51119, 51122, 68315, 26374, 68316, 68319, 77406, 77405, 77408 98733, 22990, 26379, 22989, 88479, 88481, 26512, 37353, 37355
• Recalling Firm/ Manufacturer: Medtronic Inc. Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E.; Saint Paul MN 55112
• For Additional Information Contact: Pat Fuher; 763-526-0576
• Manufacturer Reason for Recall: Medtronic CryoCath would like to inform you of an observation related to a potential leak in the hemostatic valve of the Flex Cath 12 Steerable Sheath, Model 3FC12. There wave been reports of blood and saline solution leaking out of, and air ingress into the hemostatic valve. This includes reported instances of the introduction of air bubbles through the valve during aspiration of the side port
• FDA Determined Cause: Pending
• Action: Medtronic Sales Reps began on July 15, 21011 hand delivering an "IMPORTANT MEDICAL DEVICE iNFORMATION" letter dated July 2011 to consignees. The letter identified the product, the problem, and the actions needed to be taken. The letter stated the rate of occurrence, described the potential clinical implications, and reinforced the importance of following the information found in the instructions for use as consignees continue to use the device. The letter also stated that Medtronic CryoCath is working urgently on a number of fronts to mitigate this observation and will continue to communicate with consignees as appropriate. For further information, please contact Medtronic VP of Quality at (763) 526-0576.
• Quantity in Commerce: 6712
• Distribution: Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MN, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI. and the countries of: Australia, Austria, Belgium, Canada, Czech, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Qatar, South Africa, Spain, Switzerland, and United Kingdom.
• 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 = DRA