Events

Recall of Device Recall Boston Scientific PT2 Guide Wire

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

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
    36201
  • Event Risk Class
    Class 3
  • Event Number
    Z-1540-06
  • Event Initiated Date
    2006-08-31
  • Event Date Posted
    2006-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48306
  • 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
    Guide Wire - Product Code DQX
  • Reason
    The pt2 j-tip labeled guide wires may be missing the pre-formed j-tip. as a result, guide wires may have a straight tip instead of a pre-formed j-tip.
  • Action
    An Urgent Medical Device Recall letter, dated 08/31/06, was sent to affected customers. The letter describes the issue,states that distribution or use of affected product should cease immediately and replacement product will be issued for all returned devices. A Reply Verification Tracking Form is asked to be completed and returned to Boston Scientific.

Device

Device Recall Boston Scientific PT2 Guide Wire
  • Model / Serial
    Single Pack - Outer Box UPN H7493893103J0, Inner Pouch UPN H7493893103J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8447584/8424370; 8541995/8510188; 8544020/8510187; 8577183/8503242; 8577293/8503244; 8577534/8333665; 8579728/8418259; 8580421/8406879; 8580887/8475378; 8580917/8475377; 8581079/8530796; 8585386/8503269; 8587755/8503243; 8588197/8503270; 8588877/8388791; 8591438/8376779; 8592293/8418258; 8592533/8414114; 8593589/8559710; 8593596/8539572; 8594060/8559712; 8597428/8539574; 8597830/8556834; 8598870/8388789; 8600066/8559711; 8600420/8564504; 8602812/8564506; 8603659/8567100; 8606749/8389080; 8606923/8567101; 8607935/8579186; 8607935/8556836; 8608015/8579186; 8614864/8580832; 8614869/8424371; 8615879/8567099; 8616669/8539573; 8620583/8596274; 8620754/8475382; 8628574/8596276; 8628912/8580831; 8630440/8596275; 8636284/8602641; 8636415/8602640; 8649768/8607727; 8650600/8602642; 8652901/8607728; 8654225/8602643; 8654227/8607725; 8670952/8530791; 8676700/8635975; 8685522/8649203; 8690104/8635973; 8698011/8635340; 8698012/8635972; 8698293/8653545; 8699510/8635341; 8699989/8530668; 8701815/8635976; 8702228/8530797; 8710305/8556838; 8711647/8649204; 8711691/8653546; 8711815/8661235; 8712096/8665816; 8712099/8530790; 8716342/8653547; 8722177/8683665; 8722191/8693297; 8722301/8665815; 8730052/8665814; 8731234/8695647; 8733364/8683670; 8734071/8691635; 8740494/8687514; 8741462/8661234; 8745691/8687516; 8748547/8693296; 8749063/8695649; 8750426/8708960; 8753228/8683668; 8754548/8693298; 8758129/8708968; 8758432/8719088; 8759720/8691637; 8764914/8721351; 8766444/8721352; 8766905/8708969; 8769690/8718984; 8769944/8695646; 8773040/8708966; 8773153/8691639; 8775975/8719089; 8776994/8744947; 8783863/8708965; 8784103/8708958; 8784392/8756635; 8785597/8756634; 8788048/8687515; 8789999/8760871; 8793576/8743903; 8794952/8767167; 8797558/8744946; 8798246/8760865; 8800605/8760864; 8801108/8744945.   5-pack - Outer Box UPN H7493893103J2, Inner Pouch UPN H7493893103J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8447685/8424370; 8541998/8510188; 8544019/8510187; 8577096/8475380; 8577182/8503242; 8577294/8503244; 8577535/8333665; 8580409/8418259; 8580422/8406879; 8580888/8475378; 8580918/8475377; 8581080/8530796; 8592294/8418258; 8592534/8414114; 8593591/8559710; 8593597/8539572; 8594061/8559712; 8597829/8539574; 8597831/8556834; 8598871/8388789; 8600065/8559711; 8602822/8564506; 8603658/8567100; 8606831/8389080; 8606924/8567101; 8607936/8579186; 8607936/8556836; 8608018/8579186; 8614865/8580832; 8615130/8424371; 8615880/8567099; 8616668/8539573; 8617431/8580830; 8620755/8475382; 8630441/8596275; 8636285/8602641; 8636416/8602640; 8640730/8596273; 8649767/8607727; 8650599/8602642; 8652900/8607728; 8654224/8602643; 8654226/8607725; 8676701/8635975; 8677779/8635342; 8698294/8653545; 8699851/8635341; 8699990/8530668; 8701816/8635976; 8702229/8530797; 8711692/8653546; 8711816/8661235; 8712098/8665816; 8712100/8530790; 8716343/8653547; 8722178/8683665; 8722302/8665815; 8722332/8693297; 8731237/8695647; 8733366/8683670; 8734132/8691635; 8740495/8687514; 8741463/8661234; 8748549/8693296; 8749065/8695649; 8750427/8708960; 8753229/8683668; 8754545/8708967; 8754549/8693298; 8758131/8708968; 8758433/8719088; 8759722/8691637; 8764915/8721351; 8766445/8721352; 8773154/8691639; 8774030/8743905; 8775976/8719089; 8776995/8744947; 8779683/8743904; 8783864/8708965; 8784104/8708958; 8784393/8756635; 8785598/8756634; 8788047/8687515; 8793578/8743903; 8794953/8767167; 8797559/8744946; 8798247/8760865; 8800606/8760864; 8801109/8744945.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
  • Product Description
    Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Address
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA