Guidant Corporation 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 func Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 func
Brand
Guidant Corporation
Lot Codes / Batch Numbers
200127, 200184, 200190, 200372, 200565, 201129, 201461, 201462, 201499, 401112, 452941, 453275, 453278, 453287, 453333, 453357, 453375, 453479, 453722, 453737, 594438, 594439, 594441
Products Sold
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.
Guidant Corporation is recalling PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272) pacemaker. S due to A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
Recommended Action
Per FDA guidance
INITIAL RECALL Urgent medical Device Safety Information & Corrective Action letter dated 07/18/05 was issued to physicians listing clinical Implications and patient management recommendations. EXPANDED RECALL Press was issued January 23, 2006. Urgent Medical Device Safety Information & Corrective Action letter, dated 01/21/06, was issued to physicians listing a summary of previous communication to physicians, advisory population update, and information relative to a second population of devices manufactured between October 19, 1998 and December 5, 2000. This letter gives the observed rate of occurrence, clinical implications, projected rate of occurrence and recommendations.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026