Guidant Corporation CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. Provides ventricular tachyarrhythmia and cardiac resynchronization therapies. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. Provides ventricular tachyarrhythmia and cardiac resynchronization therapies.
Brand
Guidant Corporation
Lot Codes / Batch Numbers
508822, 508827 and 508862
Products Sold
508822, 508827 and 508862
Guidant Corporation is recalling CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Content due to Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.
Recommended Action
Per FDA guidance
Sales Representatives notified 06/16/05 to return devices in their area.
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 noticeDistribution
As reported by FDA
CA, IL, MI, MO, OR, PA
Page updated: Jan 10, 2026