“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.
Worldwide Distribution USA including states of CA, CO, FL, IL, IN, KY, LA, MD, MI, MN, MO, NV, NJ, NY, OH, OK PA, TN, TX, UT, VA, and WI, and countries of LATVIA, ITALY, ARMENIA, RUSSIAN FEDERATION, POLAND, CHILE and CHINA.
Description du dispositif
Medtronic Surgical Membrane Oxygenator. || Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0 - 8.5 L/min, Sterilized Using Ethylene Oxide, REF 61399402655, Manufacturer: Medtronic Inc., Minneapolis, MN 55432-5604. || Surgical Membrane Oxygenators are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures. Additionally, the Integral Membrane Oxygenators are intended to cool and warm the blood by means of the integral heat exchange.
All states in USA (Including DC) except RI and VT.
Description du dispositif
Medtronic HMS PLUS, Hemostasis Management System, Model 30514. || It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. || It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.
IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.
“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.
“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.
“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.
“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.
“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.