Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic FlexCath 3FC12

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Medtronic FlexCath 3FC12 see related information
Date Initiated by Firm July 15, 2011
Date Posted September 12, 2011
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = MEDTRONIC CRYOCATH LP
-
-