Z-1039-05

CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac...

Name: Z-1039-05 CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac...
Creator: Guidant Corporation
Published: 2005-07-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-07-18 / Terminated

FDA source

Guidant Corporation began a recall of CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St... on 2005-07-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1039-05
Status: Terminated
Initiated: 2005-07-18
Posted: 2005-07-28
Terminated: 2007-01-05
Recalling firm: Boston Scientific Corporation
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 patient activity.
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: INITIAL RECALL 164. EXPANDED RECALL 110.
Distribution: 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.
Product codes and lots: 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

Product code LWP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)