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Terminated

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.

FDA Recall Z-3186-2011 · Posted 2011-09-12

Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
Recall StatusTerminated
Product CodeDRA
Date Initiated2011-07-15
Date Terminated2012-06-07
Product Quantity6712

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

Firm 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.

Root Cause

Pending

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102176FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10Medtronic Cryocath, LP · 2010-09-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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