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

FDA device recall Z-3186-2011 · posted 2011-09-12 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

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

Action taken

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

Status

Terminated

Product code

DRA

Quantity affected

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 count

Date initiated

2011-07-15

Date posted

2011-09-12

Date terminated

2012-06-07

Location

Saint Paul, MN

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