Z-1064-05

PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with...

Name: Z-1064-05 PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with...
Creator: Guidant Corporation
Published: 2005-06-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-06-16 / Terminated / root cause: manufacturing process

FDA source

Guidant Corporation began a recall of PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac... on 2005-06-16. The reason FDA records is "Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1064-05
Status: Terminated
Initiated: 2005-06-16
Posted: 2005-08-03
Terminated: 2005-11-17
Recalling firm: Boston Scientific 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.
Product code: KRG Programmer, Pacemaker
Reason for recall: Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Sales Representatives notified 06/16/05 to return devices in their area.
Quantity in commerce: 13
Distribution: CA, IL, MI, MO, OR and PA
Product codes and lots: 263958, 264039, 264055, 264058, 264059, 264060, 264064, 264066, 264069, 264070, 264112, 264117 and 264119

Product code KRG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)