Guidant Corporation PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . PULSAR MAX II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available; these adapt the pacing rate to the patient's changing metabolic demand. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . PULSAR MAX II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available; these adapt the pacing rate to the patient's changing metabolic demand.
Brand
Guidant Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Affected devices may be contained in the following serial number ranges. Model 1180: INITIAL RECALL serial numbers 100001 thru 100055. EXPANDED RECALL serial numbers 100117, 100140. Model 1181: INITIAL RECALL serial numbers 300001 thru 300050. EXPANDED RECALL serial number 300069 Model 1280: INITIAL RECALL serial numbers 500003 thru 500525. EXPANDED RECALL serial numbers 500034 thru 501339.
Guidant Corporation is recalling PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with gaseous ethylene oxide. 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