FDA Medical Device Recalls (openFDA)
Guidant Corporation: PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
- Recall number
- Z-1064-05
- Recalling firm
- Guidant Corporation
- Product
- PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
- 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
- 13
- Distribution
- CA, IL, MI, MO, OR and PA
- Lot, serial or model codes
- 263958, 264039, 264055, 264058, 264059, 264060, 264064, 264066, 264069, 264070, 264112, 264117 and 264119
- 510(k) numbers
- not on file
- PMA numbers
- ["P960040S015"]
- Product code
- KRG
- 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