Boston Scientific Cardiac Rhythm Management Group

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA
  • 2 Events

2 devices in the database

  • Model / Serial
    ACCOLADE™ & ACCOLADE™ MRI : L300, L301, L321 & L310, L311, L331 L200, L221 & L210, L211, L231 ESSENTIO™ & ESSENTIO™ MRI : L100, L101, L121 & L110, L111, L131 VISIONIST™ X4 : U228 VALITUDE™ X : 4 U128
  • Product Description
    pacemakers
  • Model / Serial
    Product Description: IntellaTip MiFi XP Asymmetric (N4) Curve Material Number (UPN): M004EPM4500N40 Product Description: IntellaTip MiFi XP Asymmetric (N4) Curve Material Number (UPN): M004EPM4790N40 Product Description: IntellaTip MiFi XP Asymmetric (N4) Curve Material Number (UPN): M004PM4500N40 Product Description: IntellaTip MiFi XP Asymmetric (N4) Curve Material Number (UPN): M004PM4790N40 LOT: Please refer to attachment
  • Product Description
    Catheters

One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Manufacturers representative
    Medilife s.a.l
  • Source
    RLMPH