“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.
Legendair and Supportair Portable Ventilators.
Specific ventilator codes (see FSN).
Supplied by Airox and Covidien.
These ventilators are designed primarily for use by patients at home.
The affected ventilator codes are as follows:
Legendair™ Single Branch
4095700
-
INTL LEGENDAIR SINGLE BRANCH
4095701 - GB NO LEGENDAIR SINGLE BRANCH
4095702 - DE LEGENDAIR SINGLE BRANCH
4095705 - CA LEGENDAIR SINGLE BRANCH
4095706 - JP LEGENDAIR SINGLE BRANCH
4095709 - DK LEGENDAIR SINGLE BRANCH
4095721 - AU LEGENDAIR SINGLE BRANCH
Legendair™ Double Branch
4095900 - INTL LEGENDAIR DOUBLE BRANCH
4095901 - GB NO LEGENDAIR DOUBLE BRANCH
4095902 - DE LEGENDAIR DOUBLE BRANCH
4095905 - CA LEGENDAIR DOUBLE BRANCH
4095906 - JP LEGENDAIR DOUBLE BRANCH
4095909 - DK LEGENDAIR DOUBLE BRANCH
4095921 - AU LEGENDAIR DOUBLE BRANCH
Supportair™
4096200 - INTL SUPPORTAIR
4096201 - GB SUPPORTAIR
4096202 - DE SUPPORTAIR