St. Jude warned about manufacturing problems
Device Regulation Alert: Safety, Compliance and Reimbursement News, April 27, 2009
St. Jude Medical received an FDA warning letter citing manufacturing problems mainly related to the Safire ablation catheter, the company disclosed in an SEC filing.
Physicians use ablation catheters to carefully burn heart tissue to disengage electrical signals that cause atrial fibrillation.
The FDA raised concerns about the facility after inspections conducted between December 8 and December 19, 2008, according to the filing. St. Jude detailed proposed corrective actions in a written response to the FDA.
The company believes it can resolve the problems cited in the letter and does not expect customer orders to be affected.
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