“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.
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Descripción del producto
PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. || PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide, Manufacturer Medtronic Inc Minneapolis, MN 55432-5604, Manufactured at Medtronic, Inc Villalba, Puerto Rico. || Indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3.