Z-0953-05

CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac...

Name: Z-0953-05 CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac...
Creator: Guidant Corporation
Published: 2005-06-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-06-24 / Terminated

FDA source

Guidant Corporation began a recall of CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac Resynchronization Therapy Defibrillator. Sterile EO. Guidant... on 2005-06-24. The reason FDA records is "Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0953-05
Status: Terminated
Initiated: 2005-06-24
Posted: 2005-06-30
Terminated: 2006-12-31
Recalling firm: Boston Scientific Corporation
Product: CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac Resynchronization Therapy Defibrillator. Sterile EO. Guidant Corporation, 4100 Hamiline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 4 RF devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.
FDA root cause: Other
Action: Firm issued a Dr. Doctor letter dated 06/23/05. Letter informs physicians of the issue, clinical implications and recommendations. UPDATE: An Advisory Update, dated 08/01/05 is being issued to physicians to inform them of a new programmer software application upgrade and the programmer screen alerts. Additionally regulatory approval was given for a new switch component that will be incorporated into all Guidant CRT-D products.
Quantity in commerce: 211
Distribution: worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.
Product codes and lots: all serial numbers

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)