Thomas Recalls Safesheath CSG Introducers

Reed Miller

Disclosures

February 05, 2010

February 5, 2010 (Malvern, Pennsylvania) — Thomas Medical Products, a division of GE Healthcare, is recalling certain lots of its SafeSheath CSG pacing and defibrillator lead introducers following reports that the radiopaque soft tip of the device may fragment and embolize inside a patient [1].

The FDA is classifying the voluntary recall, formally announced January 29, as class I, meaning there is a reasonable possibility that the device's malfunction could cause serious injury or death. To date, the company has received 38 reports of the introducer tip becoming separated during a procedure.

The recall covers lots of SafeSheath CSG distributed by Pressure Products between December 2005 and December 2009. The company began asking its distributor and customers to return unused products affected by the recall on December 23, 2009. The company is asking customers to contact it to arrange for return of all unused products.

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