“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.
Model Catalog: DCT (Lot serial: 0810002426 TO 0908000766 4DCT); Model Catalog: PERC (Lot serial: 0810002426 TO 0908000766 4DCT); Model Catalog: MDCT (Lot serial: 0812000028 TO 0908000232); Model Catalog: PERC (Lot serial: 0812000028 TO 0908000232); Model Catalog: DFEN (Lot serial: 0812000028 TO 0908000232); Model Catalog: DCT (Lot serial: 0812000028 TO 0908000232); Model Catalog: MDCT (Lot serial: FOR 10DFEN :); Model Catalog: PERC (Lot serial: FOR 10DFEN :); Model Catalog: DFEN (Lot serial: FOR 10DFEN :); Model Catalog: DCT (Lot serial: FOR 10DFEN :); Model Catalog: MDCT (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: PERC (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: DFEN (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: DCT (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: MDCT (Lot serial: 0810002453 TO 0908000797 8PERC); Model Catalog: PERC (Lot serial: 0810002453 TO 0908000797 8PERC); Model Catalog: DFEN (Lot serial: 0810002453 TO 0908000797 8PERC); Model C