FDA labels Medtronic letter to physicians a Class I Recall
Device Regulation Alert: Safety, Compliance and Reimbursement News, March 31, 2008
On March 21, the FDA posted a Class I Recall relating to a Medtronic letter to physicians concerning risks of inflammatory masses forming during use of Medtronic Neuromodulation Implantable Infusion Pumps.
On January 16, Medtronic sent a letter to physicians addressing the risk of inflammatory masses in patients receiving drugs through these implantable systems. The letter provided recommendations for patient management, monitoring and diagnosis.
Medtronic noted an increase in the number of reported inflammatory masses linked to this drug delivery system between 2001 and 2007, according to a Medtronic press release responding to the FDA's classification of the recall.
No deaths have been linked to the issue. Medtronic received FDA approval for updated device labeling for the infusion pumps that included reference to the risk of inflammatory masses.
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