Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
FDA device recall Z-0639-05 · posted 2005-03-18 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- Reason for recall
- The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MTD
- Quantity affected
- 6694 units were distributed.
- Distribution
- This product was distributed to 521 accounts worldwide.
- Date initiated
- 2005-02-14
- Date posted
- 2005-03-18
- Date terminated
- 2005-08-22
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONSTELLATION CATHETERS, MODEL 8031M (K021232) | Boston Scientific Corp | 2002-05-16 |
| CONSTELLATION CATHETER, MODEL 8031 (K003782) | Boston Scientific Corp | 2001-02-14 |
| CONSTELLATION CATHETERS (K000277) | Boston Scientific Corp | 2000-09-26 |
| CONSTELLATION CATHETERS, MODEL 8039 (K992777) | Boston Scientific Corp | 1999-11-12 |
| CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM (K983171) | Boston Scientific Corp | 1999-03-11 |