ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-06-80-
FDA device recall Z-2024-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- Ev3, Inc.
- Reason for recall
- ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Protege GPS stent but actually contained an 8mm x 40mm stent. This situation can lead to vessel damage or inadequate coverage of the target lesion.
- Action taken
- Consignees were emailed a letter with a subject heading of "Medical Device Recall". The e-mail was dated June 10, 2009. The letter informed the consignee of the problem and product involved. They requested that any affected devices remaining in inventory be identified and returned and to fill out and return the "Device Recall Field Action Reconciliation Form".
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 2
- Distribution
- International Distribution Only -- Brazil, Uruguay, & Malaysia.
- Date initiated
- 2009-06-10
- Date posted
- 2009-09-08
- Date terminated
- 2011-12-11
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K033314) | Ev3, Inc. | 2003-11-21 |