Events

Recall of Photo DR, Model V-230HV || Implantable Cardioverter Defibrillator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St Jude Medical.

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
    33807
  • Event Risk Class
    Class 2
  • Event Number
    Z-0146-06
  • Event Initiated Date
    2005-10-06
  • Event Date Posted
    2005-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42476
  • 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
    Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Reason
    Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
  • Action
    Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.

Device

Photo DR, Model V-230HV || Implantable Cardioverter Defibrillator
  • Model / Serial
    Serial Numbers: 30135 29709 30851 30872 32679 29370 28655 30440 31489 30258 28451 29030 28244 28786 29258 29993 31012 31031 31135 32003 32384 32419 33123 30156 29706 31918 31545 32230 30302 30691 28564 28693 28277 28982 29219 30483 11333 28660 30485 30558 30632 28563 29702 30947 30153 33000 30140 29133 30246 31978 32275 33074 40008 30511 32157 28114 30146 28025 29341 35040 31108 32148 32161 32687 33016 33087 35032 30524 31960 33088 32118 32702 28170 28595 28611 30167 31498 31523 33049 30372 32715 28703 31126 28124 29658 28754 29654 31225 29192 32513 28343 29726 30897 30900 31293 31441 31992 35039 30848 29061 32804 28208 29643 29936 29960 30373 30392 30571 30610 31904 32100 30896 31036 31190 31584 31870 28640 32252 29317 29545 31517 29562 28483 28729 30137 29716 31553 29295 29637 29765 29931 30371 30477 30776 30834 32798 32978 31818 30126 35061 29017 32639 29167 29552 31295 32069 28878 29410 28682 32786 28552 30266 31912 30425 28458 29189 31274 32494 32851 28419 28433 32686 30163 28080 30364 31154 28148 28522 29796 30710 31372 29627 29399 31536 32836 31989 29345 29648 29664 29850 29677 30161 32120 32603 28597 30491 29090 30220 30476 30493 33103 11301 28716 28818 29103 29340 29632 30731 32646 28372 29452 31420 28507 28286 28088 32378 32949 29969 28059 29100 29269 30857 24297 29134 30671 33028 35055 32177 28737 32601 29790 30523 30880 29297 31371 28765 28001 29263 29424 31943 31979 28767 29303 29944 30283 30395 30448 30636 32212 29179 29142 29538 30197 30784 30132 32490 35045 35060 30751 28739 29939 30282 32012 30526 33188 28476 35080 29222 29386 29400 32246 32255 32852 28355 28920 29793 30185 30964 31493 31519 32021 32706 28883 30787 31174 31507 30688 35095 29245 32248 32429 30455 30700 30712 32182 32539 32097 28602 28300 29588 30975 30357 28813 35077 28924 30278 28287 28407 30971 29707 32862 32965 32249 30914 31183 30127 32056 32967 40076 30277 31389 29780 30409 31297 31461 28110 28175 28495 28772 29298 29320 31591 31920 29139 28929 28608 31321 28251 29327 32053 29668 29692 30038 31867 30193 32881 28757 31286 32481 28571 30867 28596 29113 29065 29068 28482 30464 11325 28828 30285 30676 30894 31122 31360 31482 31535 31541 31919 32695 33008 33132 35029 35106 11242 28234 28299 28398 29323 32390 28514 32537 30215 29231 28659 28807 28079 32878 28892 28417 31993 31058 29212 30240 28426 31115 31155 32449 32703 32899 33040 30998 28271 29122 30061 35063 28115 28215 28995 29659 30007 30101 30355 31302 32472 32647 33026 31599 30908 31393 33108 31875 33029 32704 28026 28775 30850 32121 33107 30759 29816 28272 28628 30019 31165 28804 30190 30556 32239 32585 28726 29758 30347 30471 31940 35066 29564 29704 29811 29900 30421 30489 32438 32648 32656 32699 35030 35070 40009 28104 30486 29943 31456 31187 28127 28383 29495 29872 29926 30017 30233 30380 30472 30818 28146 29084 29116 24172 29411 32470 29124 28894 28902 28763 29493 30259 32613 30232 31310 11378 24086 29232 29671 30666 32036 31325
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Western Europe: Austria Belgium Denmark Finland France Germany Italy Netherlands Poland Portugal Spain Sweden UK Switzerland Greece Malta Eastern Europe: Czech Republic Lithuania Latvia Romania Bulgaria Croatia Slovenia Slovakia Russia Serbia Middle East! Africa: South Africa Israel Iran Iraq Jordan Lebanon Suadi Arabia Turkey Latin America: Argentina Brazil Chile Colombia EI Salvador Guatamala Mexico Uruguay Venezuela Asia-Pacific: China Hong Kong Malaysia Taiwan Thailand Australia-New Zealand: Australia New Zealand and Canada
  • Product Description
    Photo DR, Model V-230HV || Implantable Cardioverter Defibrillator
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Manufacturer Address
    St Jude Medical, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA