Events

Recall of Device Recall Medtronic FlexCath 3FC12

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc. Cardiac Rhythm Disease Management.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59477
  • Event Risk Class
    Class 2
  • Event Number
    Z-3186-2011
  • Event Initiated Date
    2011-07-15
  • Event Date Posted
    2011-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102863
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, steerable - Product Code DRA
  • 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.
  • 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.

Device

Device Recall Medtronic FlexCath 3FC12
  • Model / Serial
    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 Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA