Guidant Corporation CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The Guidant CONTAK TR CHFD congestive heart failure devices are multiprogrammable dual-chamber devices that offer adaptive-rate congestive heart failure pacing therapy. CONTAK TR devices use an accelerometer that allows the pacing rate to adapt to the patient's changing metabolic demand as it responds to pat Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The Guidant CONTAK TR CHFD congestive heart failure devices are multiprogrammable dual-chamber devices that offer adaptive-rate congestive heart failure pacing therapy. CONTAK TR devices use an accelerometer that allows the pacing rate to adapt to the patient's changing metabolic demand as it responds to pat
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. INITIAL RECALL serial numbers 200128 thru 200479. EXPANDED RECALL serial numbers 200076 thru 200958
Guidant Corporation is recalling CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporatio 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