Recall Z-3186-2011 ยท DRA Catheter, Steerable
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, aspirat
| Date | Sep 12, 2011 (initiated Jul 15, 2011) |
| Status | Terminated |
| 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 communi |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102176 | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 Medtronic Cryocath, LP, Sep 1, 2010 |