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
  • 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
  • 1 Event

Manufacturer

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

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Single Pack - Outer Box UPN H7493893101J0, Inner Pouch UPN H7493893101J0 with the following Outer Box Batch number / Inner Pouch Batch number: 854993/8506164; 8553464/8506163; 8558452/8506162; 8580516/8418120; 8581252/8414121; 8601289/8567104; 8601977/7567103; 8611497/8390776; 8618382/8414119; 8625209/8525244; 8630091/8602645; 8630092/8599793; 8637044/8599796; 8639684/8602647; 8642791/8599795; 8643583/8616749; 8645466/8616759; 8646331/8616971; 8650221/8599794; 8656280/8616970; 8656289/8612088; 8662274/8599797; 8662896/8616760; 8666532/8632041; 8668106/8602646; 8669915/8642147; 8681003/8641004; 8684067/89641006; 8694117/8642148; 8697663/8525245; 8699505/8642146; 8709594/8519073; 8749798/8713578; 8752423/8695650; 8761674/8721471; 8762199/8721350; 8774436/8742235; 8782981/8755555; 8783262/8742236; 8784950/8739386; 8795581/8755557; 8797321/8757433.   5-pack - Outer Box UPN H7493893101J2, Inner Pouch UPN H7493893101J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8553465/8506163; 8558453/8506162; 8642073/8607723; 8642792/8599795; 8643584/8616749; 8645467/8616759; 8646332/8616971; 8646667/8607724; 8650220/8599794; 8654220/8612089; 8656281/8616970; 8656290/8612088; 8662275/8599797; 8667578/8641003; 8668107/8602646; 8669916/8642147; 8677642/8519074; 8681004/8641004; 8683824/8530667; 8696525/8642150; 8697664/8525245; 8699506/8642146; 8776585/8739387.
  • Product Classification
  • 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 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. 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
  • Model / Serial
    Single Pack - Outer Box UPN H7492893102J0, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616992/8498451; 8634476/8576268; 8637834/8592512; 8642641/8542687; 8687373/8644753; 8687380/8620072; 8693389/8644751.   5-pack - Outer Box UPN H7493893102J2, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616993/8498451; 8619932/8428652; 8634477/8576268; 8637835/8592512; 8642642/8542687; 8687374/8644753; 8687381/8620072; 8693471/8644751; 8745684/8677736.
  • Product Classification
  • 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 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . 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
  • Model / Serial
    Single Pack - Outer Box UPN H7493893104J0, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578445/8498450; 8615997/8579187; 8616986/8428651; 8625889/8542669; 8634387/8592510; 8661236/8615192; 8676306/8623927; 8679477/8614968; 8684638/8614969; 8691987/8614967; 8711404/8615194; 8711707/8640992; 8716167/8615190; 8775301/8721349.     5-Pack - Outer Box UPN H7493893104J2, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578446/8498450; 8615998/8579187; 8616987/8428651; 8625890/8542669; 8634388/8592510; 8661241/8615192; 8676307/8623927; 8679478/8614968; 8684639/8614969; 8691990/8614967; 8711405/8615194; 8711708/8640992; 8716168/8615190; 8775302/8721349.
  • Product Classification
  • 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 300cm J-Tip, Catalog Number 38931-04. 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