Medtronic Kappa/Sigma pacer recall is Class I

Firm's May 18 "Dear Doctor" letter advising of potential wire separations in certain Kappa and Sigma pacemakers is deemed a Class I recall by FDA, the most serious category, the agency announces June 11. Medtronic had warned that wire separations in certain models could cause a loss of rate response, premature battery depletion, loss of telemetry or no output. Therefore, the firm advised that physicians consider device replacement for patients who are pacemaker-dependent. Medtronic has made no new recommendations as a result of the recall classification (1"The Gray Sheet" May 25, 2009, p. 15)