Guidant Corporation INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . INTELIS II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering both adaptive-rate therapy and conventional pacing therapy. These pacemakers provide various levels of therapeutic and diagnostic functionality. INTELIS II adaptive-rate models have an accelerometer, which is a mo Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . INTELIS II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering both adaptive-rate therapy and conventional pacing therapy. These pacemakers provide various levels of therapeutic and diagnostic functionality. INTELIS II adaptive-rate models have an accelerometer, which is a mo
Brand
Guidant Corporation
Lot Codes / Batch Numbers
800001, 800002, 800003, 800004. Model 1499: Serial numbers 200001 thru 200073.
Products Sold
Affected devices may be contained in the following serial number ranges. Model 1349: Serial numbers 100003 thru 100076. Model 1384: Serial numbers 300000 thru 300073. Model 1385: INITIAL RECALL serial numbers 400005 thru 400019. EXPANDED RECALL serial numbers 400003, 400004. Model 1483: Serial numbers 600005 thru 600082. Model 1484: Serial numbers 700005 thru 700064. Model 1485: INITIAL RECALL serial numbers 800005 thru 800053. EXPANDED RECALL serial numbers 800000, 800001, 800002, 800003, 800004. Model 1499: Serial numbers 200001 thru 200073.
Guidant Corporation is recalling INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized with gas 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