Z-3186-2011

Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter...

Name: Z-3186-2011 Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2011-07-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-07-15 / Terminated

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for... on 2011-07-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3186-2011
Status: Terminated
Initiated: 2011-07-15
Posted: 2011-09-12
Terminated: 2012-06-07
Recalling firm: Medtronic, Inc.
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.
Product code: DRA Catheter, Steerable
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 root 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.
Product codes and lots: 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

Product code DRA

K102176Class IIFlexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3Fc12, 3Fc10Medtronic Cryocath, LP / cleared 2010-09-01

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)