Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama.
Description du dispositif
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. || Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.
“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.