Yet More Recalls from Guidant
These last few days Boston Scientific initiated its second wave of recalls for Guidant products. Boston Scientific is now recalling some Insignia and Nexus pacemakers, Contak Renewal TR and TR 2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality, and Vitality 2 ICDs (implantable cardioverter defibrillators). According to the AP the company expects it will take up to two years to sort out all the pending problems with Guidant devices. In a letter (pdf) sent to patients on June 23, the company stated that “[s]ome of these devices have been found to contain a component that may prevent the device from delivering therapy or may lead the device battery to run out before it should. These components are from select lots from a single supplier. Not all devices with this component are affected.” The letter also recommends that patients see their doctor to check their device.
Another letter (pdf) sent to doctors on the same day notified them of five reports of device malfunction because of the failure of a low-voltage capacitator from a single component supplier. No deaths have been associated with this issue but two pacemaker patients have been reported to have experienced syncope because of loss of pacing output.
These warnings affect 27,000 implanted devices. The recalls affect another 22,600 units to be returned by the company’s salesforce and customers who have them in stock.
Related entry: Boston Scientific Phasing Out Guidant Brand.
June 27, 2006 Related topics: Product Recalls, Cardiology