Device Recall PULSAR and PULSAR MAX pacemaker

Affected devices may be contained in the following serial number ranges.  Model 470: INITIAL RECALL serial numbers 101150 thru 101894. EXPANDED RECALL serial numbers 101188 thru 102201. Model 870: INITIAL RECALL serial numbers 200201 thru 201205. EXPANDED RECALL serial numbers 200125, 200127, 200184, 200190, 200372, 200565, 201129, 201461, 201462, 201499, 201613. Model 970: INITIAL RECALL serial numbers 300808 thru 301676. EXPANDED RECALL serial numbers 300555 thru 301709 Model 972: INITIAL RECALL serial numbers 452959 thru 454562. EXPANDED RECALL serial numbers 401085, 401112, 452941, 453275, 453278, 453287, 453333, 453357,  453375, 453479, 453722, 453737, 454073  Model 1170: INITIAL RECALL serial numbers 100610 thru 103665. EXPANDED RECALL serial numbers 100213 thru 106149. Model 1171: INITIAL RECALL serial numbers 300733 thru 302575. EXPANDED RECALL serial numbers 300378 thru 303251, 594438, 594439, 594441, 594442. Model 1172: INITIAL RECALL serial numbers 594273 thru 594437. EXPANDED RECALL serial numbers 594293 thru 594417. Model 1270: INITIAL RECALL serial numbers 595951 thru 608303. EXPANDED RECALL serial numbers 500254 thru 619402. Model 1272: INITIAL RECALL serial numbers 600250 thru 600749. EXPANDED RECALL serial numbers 600265 thru 600823.

Cardiovascular Devices

3

Yes

worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cyprus, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guyana, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Singapore,Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan ROC, Turkey, United Kingdom, Uruguay and Venezuela. EXPANDED RECALL additional countries include: China, Croatia, Korea. Lithuania, Madagascar, Maldives, Malta, Monaco, Nepal and Thailand.

PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. PULSAR and PULSAR MAX pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, many offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available with the adaptive-rate models; these adapt the pacing rate to the patient's changing metabolic demand.