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Class 2 Device Recall VENTAK, PRIZM 2 DR ICD |
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| Date Initiated by Firm |
June 16, 2005 |
| Date Posted |
August 03, 2005 |
| Recall Status1 |
Terminated 3 on November 17, 2005 |
| Recall Number |
Z-1064-05 |
| Recall Event ID |
32495 |
| PMA Number |
P960040S015 |
| Product Classification |
Programmer, Pacemaker - Product Code KRG
|
| 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. |
| Code Information |
263958, 264039, 264055, 264058, 264059, 264060, 264064, 264066, 264069, 264070, 264112, 264117 and 264119 |
Recalling Firm/
Manufacturer |
Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
|
Manufacturer Reason
for Recall |
Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.
|
FDA Determined
Cause 2 |
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 |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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