EV3 INC.

6 devices in the database

  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    TRAP Cardiovascular and Neurovascular
  • Model / Serial
    Model Catalog: (Lot serial: 2681547); Model Catalog: (Lot serial: 1940695); Model Catalog: (Lot serial: 1940667)
  • Product Description
    IntraStent LD Max
  • Model / Serial
    Model Catalog: AB14W025120150 (Lot serial: 9416365); Model Catalog: AB14W020080150 (Lot serial: 8778807); Model Catalog: AB14W020120150 (Lot serial: 9416365); Model Catalog: AB14W020080150 (Lot serial: 9416365); Model Catalog: AB14W025120150 (Lot serial: 9248597); Model Catalog: AB14W020120150 (Lot serial: 9248597); Model Catalog: AB14W020080150 (Lot serial: 9248597); Model Catalog: AB14W025120150 (Lot serial: 8815410); Model Catalog: AB14W020120150 (Lot serial: 8815410); Model Catalog: AB14W020080150 (Lot serial: 8815410); Model Catalog: AB14W025120150 (Lot serial: 8811586); Model Catalog: AB14W020120150 (Lot serial: 8811586); Model Catalog: AB14W020080150 (Lot serial: 8811586); Model Catalog: AB14W025120150 (Lot serial: 8784857); Model Catalog: AB14W020120150 (Lot serial: 8784857); Model Catalog: AB14W020080150 (Lot serial: 8784857); Model Catalog: AB14W025120150 (Lot serial: 8778807); Model Catalog: AB14W020120150 (Lot serial: 8778807)
  • Product Classification
  • Product Description
    NANOCROSS .014" OTW PTA DILATION CATHETER
  • Model / Serial
    Model Catalog: XR-CS1200-55 (Lot serial: SN 1343045); Model Catalog: XR-CS1150-45 (Lot serial: SN 1343045); Model Catalog: XR-CS1200-55 (Lot serial: SN 1343019); Model Catalog: XR-CS1150-45 (Lot serial: SN 1343019); Model Catalog: XR-CS1200-55 (Lot serial: SN 1326974); Model Catalog: XR-CS1150-45 (Lot serial: SN 1326974); Model Catalog: XR-CS1150-45 (Lot serial: SN 1364082); Model Catalog: XR-CS1150-45 (Lot serial: SN 1342882); Model Catalog: XR-CS1200-55 (Lot serial: SN 1342882); Model Catalog: XR-CS1150-45 (Lot serial: SN 1342957); Model Catalog: XR-CS1200-55 (Lot serial: SN 1342957); Model Catalog: XR-CS1200-55 (Lot serial: SN 1364082)
  • Product Description
    X-Sizer Catheter System
  • Model / Serial
    Model Catalog: XR-CS1200-55 (Lot serial: 407855)
  • Product Description
    X-Sizer Catheter System
One more

6 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    FSSH
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    BAM
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    BAM
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    VNSAWH
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA
One more