RunWay Guide Catheter

Manufacturer

  • 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.”
  • Source
    DH

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    2013040058
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    TX and Russia
  • Product Description
    Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
  • Manufacturer
  • Model / Serial
    Model Catalog: 38969-122 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-10 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-09 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-08 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-07 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-06 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-05 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-04 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-02 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-01 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-03 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-578 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-576 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-575 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-574 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-573 (Lot serial: ASSORTED BATCH NUMBERS); Model Catalog: 38969-539
  • Product Classification
  • Product Description
    6F RUNWAY GUIDE CATHETER
  • Manufacturer