Events

Recall of Device Recall INTROFLEX VALVE INTRODUCER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences, Llc.

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
    52629
  • Event Risk Class
    Class 2
  • Event Number
    Z-1913-2009
  • Event Initiated Date
    2009-05-11
  • Event Date Posted
    2009-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83492
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Edwards lifesciences llc received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.
  • Action
    Edwards LifeSciences LLC initiated the worldwide recall via customer letters dated May 11, 2009 and are being sent by Federal Express stating that customers cease using affected product from the indicated lots and return all unused products. The firm requested that the customer provide written verification of stock and identify any unused product to be returned. For further information, contact Edwards LifeSciences LLC Customer Service at 1-800-424-3278.

Device

Device Recall INTROFLEX VALVE INTRODUCER
  • Model / Serial
    Model Number: 1350BF85, Lot Numbers:  58501071, 58516969, 58545402, 58568606, 58584153, 58606248, 58624009, 58648809, 58503807, 58532828, 58549292, 58573256, 58594977, 58611630, 58626772, 58652695, 58511627, 58536781, 58552776, 58576340, 58598946, 58611631, 58630984, 58653740, 58516967, 58536782, 58559223, 58577684, 58602066, 58618047, 58636148, 58653741, 58516968, 58541155, 58559224, 58577685, 58606247, 5864008 and 58645016;  Model Number: 1351BF7, Lot Numbers: 58530069, 58545403, 58598947 and 58657088;  Model Number: 1351BF85H, Lot Numbers: 58526054, 58532992, 58534647, 58552777, 58559225, 58576341, 58594979, 58594980, 58598948, 58602067, 58624011, 58630985, 58636149, 58648810 and 58657097;  Model Number: 1450BF85, Lot Numbers: 58511628, 58516970, 58577686, 58589282, 58598949, 58615054, 58624015, 58635275 and 58664034; Model Number: 1451BF6, Lot Numbers: 58506614, 58526055, 58562341, 58577589, 58594981, 58615056, 58621700, 58635275, 58657143 and 58664035;  Model Number: 1451BF8, Lot Numbers: 58511629, 58514509, 58514513, 58530070, 58532829, 58541156, 58549294, 58556099, 58564225, 58568607, 58573257, 58584154, 58602069, 58606249, 58610319, 58615059, 58621701, 58648811, 58652696, 58660278 and 58685275;  Model Number: 1452BF85H, Lot Numbers: 58503809, 58549295, 58576343, 58611633, 58630986 and 586652697; Model Number: 1550BF6C, Lot Numbers: 58499574, 58501074, 58530071, 58532830, 58562343, 58602070, 58626774 and 58652698; Model Number: 1550BF7C, Lot Numbers: 58564227, 58577700 and 58657145; Model Number: 1550BF8, Lot Numbers: 58499575, 58526057, 58549298, 58560116, 58564228 and 58573260; Model Number: 1550BF85, Lot Numbers: 58501075, 58530072, 58534652, 58536809, 58577701, 58598950, 58618048 and 58657146; Model Number: 1551BF85H, Lot Numbers: 58615062, 58630987 and 58652699; Model Number: 1650BF85, Lot Numbers: 58545404, 58564229, 58584155, 58589283, 58618049, 58645018 and 58660284; Model Number: 1651BF85, Lot Numbers: 58499633, 58501080, 58511630, 58541157, 58556100, 58559226, 58584156, 58602071, 58615072, 58621702, 58645019 and 58652700; Model Number: 1652BF85H, Lot Numbers:  58511631, 58549300, 58606253 and 58648812; Model Number: S310740C, Lot Number: 58550203; and Model Number: S5507BF85, Lot Numbers: 58496258, 58535112, 58604814 and 58644423.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: United States (AL, AR, CA, CO, CT, DC, FL, GA, IA, IL, IN,KS, KY, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, VA, WV, HI and PR), Austria, Canada, Switzerland, Czech,republic, Germany, Denmark, Algeria, Estonia, Egypt, Spain, Finland, France, Great Britain, Hungary, Iceland, Ireland, Italy, Kuwait, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Sweden, Slovak republic, Tunisia, Turkey, Aruba, Hong Kong, Malaysia and Singapore.
  • Product Description
    Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. || Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • Manufacturer Address
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA