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.
This recall has been terminated (originally issued August 3, 2005).
- Company
- Guidant Corporation
- Recall Initiated
- June 16, 2005
- Posted
- August 3, 2005
- Terminated
- November 17, 2005
- Recall Number
- Z-1065-05
- Quantity
- 3
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.
Distribution
CA, IL, MI, MO, OR and PA
Lot / Code Info
508822, 508827 and 508862
Root Cause
Other
Action Taken
Sales Representatives notified 06/16/05 to return devices in their area.
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