Z-1194-06

Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M159), CONTAK RENEWAL...

Name: Z-1194-06 Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M159), CONTAK RENEWAL...
Creator: Guidant Corporation
Published: 2006-05-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-05-15 / Terminated

FDA source

Guidant Corporation began a recall of Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M159), CONTAK RENEWAL 4 AVT (models M170, M175), CONTAK RENEWAL 4 AVT... on 2006-05-15. The reason FDA records is "Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1194-06
Status: Terminated
Initiated: 2006-05-15
Posted: 2006-07-04
Terminated: 2007-01-06
Recalling firm: Boston Scientific Corporation
Product: Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M159), CONTAK RENEWAL 4 AVT (models M170, M175), CONTAK RENEWAL 4 AVT HE (models M177, M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Reason for recall: Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and beeping.
FDA root cause: Other
Action: The recall was initiated on May 15, 2006, with a press release and a letter to physicians. Physicians are asked to review the specific positioning of each device for patients implanted with affected models. This is a review of medical records to determine if the device is subpectoral. Then use of an AP radiograph on patients with a subpectoral implant to determine device orientation and if leads exit in a clockwise direction. In those cases, it''s recommended physicians advise the patient of the potential for failure, and follow-up at least once per quarter per device labeling and consider device replacement for larger muscle/active patients or for patients who regularly utilize therapy. Physicians are instructed to orient device with the serial number facing away from the ribs for future implants.
Quantity in commerce: 54,971 devices have been distributed however this only affects those that have been implanted subpectorally with the serial number facing the ribs.
Distribution: Nationwide, US Virgin Islands, Puerto Rico and worldwide to include: Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Polynesia, Portugal, Qatar, Russia, Saint Lucia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, West Indies.
Product codes and lots: Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Guidant.

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)