The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . a
FDA device recall Z-0707-03 · posted 2003-04-02 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances.
- Action taken
- The firm sent via Federal Express Overnight delivery, a notification letter entitled 'IMPORTANT PRODUCT INFORMATION ALERT' dated 2/3/2003 to all user hosptial accounts. The letter warns them of the possibility of partial deployment and how to avoid it. There is no request to stop using or to return the product. The firm considers the action a 'Safety Alert'.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 32000
- Distribution
- Product was distributed to 1141 user/medical facilities nationwide.
- Date initiated
- 2003-02-03
- Date posted
- 2003-04-02
- Date terminated
- 2010-09-08
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K023217) | Cordis Corp. | 2002-10-25 |
| SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K021898) | Cordis Corp. | 2002-08-14 |