(1)8FEN
Starting Lot Number: 0910000342
Ending Lot Number: 1101001558
Starting Lot Number: 110201893X
Ending Lot Number: 120600700X
(2)8LPC
Starting Lot Number: 0910000346
Ending Lot Number: 1101001823
Starting Lot Number: 110200327X
Ending Lot Number: 120600351X
(for more code see attached)
“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.