Implanted Infusion Pump Medtronic Technical Name: Synchromed II 8637-20 / Synchromed II 8637-40 ANVISA Registration Number: 10339190229 Hazard Class: IV Affected Model: 8637-20 and 8637-40 Serial Numbers Affected: PUMP 8637 -20 SM2 20ML EMAN US JUN BATRY; PUMP 8637-20 SM2 20ML PAP MAN US JUN BAT; PUMP 8637-20 SM2 20ML PAPER MAN USMKT SL; PUMP 8637-20 SM2 20ML PAPR MAN USMKTJUNC PUMP 8637-20 SYNCH II 20ML US MKT SL; PUMP 8637-20 SYNCHMED II 20ML PF; PUMP 8637-20 SYNCHMED II PCKT FILL L105; PUMP 8637-20 SYNCHROMED II L089; PUMP 8637-20 SYNCHROMED II OUS L105; PUMP 8637-40 SYNCHMED II PCKT FILL L105; PUMP 8637-40 SYNCHROMED II L089; PUMP 8637-40 SYNCHROMED II OUS L105.

“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.