ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26, ev3, 4600 Nathan Lane North, Plymouth, MN 554
FDA device recall Z-1127-2008 · posted 2008-05-06 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Action taken
- ev3 notified all consignees via "Medical Device Recall" letter on 1/18/08. The letter was addressed to the Hospital and it described the device affected and the problem. The letter provided recommendations to segregate the affected devices and requested the return of the "Device Recall Field Action Reconciliation Form."
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 107
- Distribution
- Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARAB
- Date initiated
- 2008-01-18
- Date posted
- 2008-05-06
- Date terminated
- 2008-11-04
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ITI STENT (K980290) | Intratherapeutics, Inc. | 1998-07-21 |