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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Guidant Corporation
Lot Codes / Batch Numbers
263958, 264039, 264055, 264058, 264059, 264060, 264064, 264066, 264069, 264070, 264112, 264117 and 264119
Products Sold
263958, 264039, 264055, 264058, 264059, 264060, 264064, 264066, 264069, 264070, 264112, 264117 and 264119
Guidant Corporation is recalling PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterili 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