Z-0908-05

CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide. Guidant...

Name: Z-0908-05 CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide. Guidant...
Creator: Guidant Corporation
Published: 2005-06-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-06-17 / Terminated

FDA source

Guidant Corporation began a recall of CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide. Guidant corporation, Cardiac Rhythm Management, 4100 Hamline Avenue... on 2005-06-17. The reason FDA records is "Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0908-05
Status: Terminated
Initiated: 2005-06-17
Posted: 2005-06-30
Terminated: 2007-01-10
Recalling firm: Boston Scientific Corporation
Product: CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide. Guidant corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.
FDA root cause: Other
Action: Dear Doctor letter was dated and issued 06/17/05 informing Doctors of an shorting issue of the Renewal 1 & 2 CRT-D devices. The letter gave indications of device failure and recommendations for patient visits. A press release was also issued on 06/17/05.
Quantity in commerce: 16,000 (Approximately 11,900 remain implanted worldwide) - both products combined
Distribution: worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom and Venezuela.
Product codes and lots: RENEWAL 2 (model H155) serial number range 173277 - 777182 includes CRT-Ds manufactured on or before August 26, 2004.

Product code NIK

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)