Home » Recalls: Medtronic pulls Trivantage tracheal tube, Paradigm and Polyfin insulin pumps
Recalls: Medtronic pulls Trivantage tracheal tube, Paradigm and Polyfin insulin pumps
June 21, 2013 By Brad Perriello
Medtronic (NYSE:MDT) issued a Class I recall of its Trivantage endotracheal tubes in the U.S. and warned of potential risks from its Paradigm and Polyfin insulin infusion sets in Canada.*
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.
*Correction, June 26, 2013: This article originally stated that Medtronic pulled its Paradigm and Polyfin insulin infusions sets in Canada. Return to the corrected sentence.
Filed Under: Food & Drug Administration (FDA), News Well, Recalls, Respiratory Tagged With: Health Canada, Insulin Management, Minnesota
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