St. Jude Medical

What is this?

Company behind the production of a medical device. It is usually the firm that initiates the event.

30 devices in the database

  • Model / Serial
    C408502, C408527; C408513, C408524 | C408502 (3110892, 3118797,); C408527 (3105838); C408513 (3107645); C408524 (3109782)
  • Product Classification
  • Product Description
    MD: Cardiac device introducer
  • Model / Serial
    1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592, 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 | all | all
  • Product Classification
  • Product Description
    AIMD: Implantable defibrillator lead
  • Model / Serial
    1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592, 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 | all
  • Product Classification
  • Product Description
    AIMD: Implantable defibrillator lead
  • Model / Serial
    LDA 220 Q52, LDA 220 Q58, LDA 220 Q65 and LDP 220 Q58 | Total of 1121 leads are affected. Of which 164 have been implanted or are in hospital inventory outside US.
  • Product Classification
  • Product Description
    AIMD: Endocardial defibrillation lead
  • Model / Serial
    All | All
  • Product Classification
  • Product Description
    AIMD: Defibrillator, implantable
25 more

38 manufacturers with a similar name

Learn more about the data here.

  • Manufacturer Address
    St. Jude Medical Cardiovascular Division, 14901 Deveau Pl, Minnetonka MN 55345-2126
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • Manufacturer Address
    St. Jude Medical Inc, 240 Santa Ana Ct, Sunnyvale CA 94085-4512
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • Manufacturer Address
    St. Jude Medical, 575 Route 73 North, Bldg D, Cooper Run Executive Park, West Berlin NJ 08091
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • Manufacturer Address
    St. Jude Medical, 14901 DeVeau Place, Minnetonka MN 55345
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • Manufacturer Address
    St. Jude Medical Atrial Fibrillation Division Inc, 240 Santa Ana Ct, Sunnyvale CA 94085-4512
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
33 more