U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Percutaneous Catheter - Product Code DQY
원인
Catheter may crack near the radiopaque marker band at the distal end of the device during use. cracking of the catheter shaft in this location can result in material separation, and potential embolization.
조치
Consignees were sent a Medical Device Recall letter, dated 11/6/09. The letter was addressed to Risk Manger or Cath Lab Manage. The letter provided the Issue Summary, identified the Affected Product, and stated the Required Action, which asked consignees to locate and remove the affected product. Questions should be directed to ev3 Customer Service at 800-716-6700.
Nationwide Distribution -- USA, including states of CA, FL, GA, IL, IN, IA, KS, KY, MI, MT, NJ, PA, SD, TN, TX, and WI.
제품 설명
TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. || US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, || SC-014-150, SC-018-150, SC-035-090, and SC-035-150. || Intended to guide and support a guide wire during access of the vasculature.
“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.