EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
FDA device recall Z-0306-05 · posted 2004-12-15 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Research Medical Inc
- Reason for recall
- Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.
- Action taken
- All consignees were notified by letter on 11/22/2004
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 396 units
- Distribution
- AL, CA, CO, FL, GA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OR, PA, RI, TN, TX, VA, WA, and WI. No foreign, military or government distribution.
- Date initiated
- 2004-11-19
- Date posted
- 2004-12-15
- Date terminated
- 2005-01-07
- Location
- Midvale, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 (K020693) | Embol-X, Inc. | 2002-09-05 |