The Fridley, Minn.-based medical device company said it received reports that Trivantage products distributed from July 27, 2012, through Feb. 14 are prone to "cuff leak" or "cuff deflation" when the inflation valve cap is inappropriately removed (pulled off, instead of snapped-off sideways).
"This requires the physician to re-inflate or replace the deflated tube to ensure the continued breathing support of the patient. Use of this recalled product can result in serious adverse health consequences, including death," according to an FDA notice.
North of the border, Medtronic Canada Ltd. said it received 2 reports of its Paradigm and Polyfin infusion pumps on the under- or over-delivery of insulin, the Brampton Guardian reported.
"This may cause hypoglycemia (low blood sugar) or hyperglycaemia (high blood sugar), and in extreme cases, may cause the loss of consciousness or death, said Health Canada," the newspaper reported.
Medtronic is informing patients, healthcare providers and pharmacies in Canada of the potential problem, to explain how to avoid it, according to the newspaper.