Life Sciences

FDA: Medtronic voluntary recall of catheter is Class I recall

Device Regulation Alert: Safety, Compliance and Reimbursement News, April 13, 2009

The FDA is classifying Medtronic’s voluntary recall for three models of the BioGlide Ventricular Snap Shunt Catheter as a Class I recall, according to a company release.

A Class I recall is issued when “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Read more about Medtronic’s Class I recall.

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