Recall Z-0639-05 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
Boston Scientific
Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
| Date | Mar 18, 2005 (initiated Feb 14, 2005) |
| Status | Terminated |
| Reason | The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events. |
| Root cause | Other |
| Action | All consignees were notified via customer letters sent out on 02/14/2005. Distributors outside the US will be formally notified via the firm's recall procedures. |
| Quantity | 6694 units were distributed. |
| Distribution | This product was distributed to 521 accounts worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000277 | CONSTELLATION CATHETERS Boston Scientific Corp, Sep 26, 2000 |
| K003782 | CONSTELLATION CATHETER, MODEL 8031 Boston Scientific Corp, Feb 14, 2001 |
| K021232 | CONSTELLATION CATHETERS, MODEL 8031M Boston Scientific Corp, May 16, 2002 |
| K983171 | CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM Boston Scientific Corp, Mar 11, 1999 |
| K992777 | CONSTELLATION CATHETERS, MODEL 8039 Boston Scientific Corp, Nov 12, 1999 |