Medtronic Inc. Cardiac Rhythm Disease Management: 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.

Recall number

Z-3186-2011

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

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.

Status

Terminated

Initiated

2011-07-15

Posted

2011-09-12

Terminated

2012-06-07

Reason

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

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

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.

Lot, serial or model codes

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

510(k) numbers

["K102176"]

PMA numbers

not on file

Product code

DRA

Firm FEI

2182208

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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