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Terminated

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.

FDA Recall Z-1064-05 · Posted 2005-08-03

Recalling FirmGuidant Corporation
Recall StatusTerminated
Product CodeKRG
Date Initiated2005-06-16
Date Terminated2005-11-17
Product Quantity13

Reason for Recall

Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.

Firm Action

Sales Representatives notified 06/16/05 to return devices in their area.

Root Cause

Other

Distribution Pattern

CA, IL, MI, MO, OR and PA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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