Hydrophilic microguide mod X-CELERATOR 0.010 "300cm, Hydrophilic microguide mod X-CELERATOR 0.014" 300cm, || MARATHON 1.5F / 2.7F microcatheter 165cm guide 0.010 "|| 25cm, ALLIGATOR recovery system 2mm 175cm || OD 0.40mm, ALLIGATOR recovery system 3mm || 175cm OD 0.40mm, ALLIGATOR RETRIEVALDEVICE. 4mm, || all batches with Expiration date between June 2017 and || August 2019.
“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.