Recall Z-1064-05 ยท KRG Programmer, Pacemaker
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.
| Date | Aug 3, 2005 (initiated Jun 16, 2005) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.