FDA Medical Device Recalls (openFDA)
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 number
- Z-1065-05
- Recalling firm
- Guidant Corporation
- 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.
- Status
- Terminated
- Initiated
- 2005-06-16
- Posted
- 2005-08-03
- Terminated
- 2005-11-17
- Reason
- Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.
- Root cause
- Other
- Action
- Sales Representatives notified 06/16/05 to return devices in their area.
- Quantity
- 3
- Distribution
- CA, IL, MI, MO, OR and PA
- Lot, serial or model codes
- 508822, 508827 and 508862
- 510(k) numbers
- not on file
- PMA numbers
- ["P010012S008"]
- Product code
- NIK
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28