Recall Z-2024-2009
Ev3, Inc. · initiated June 10, 2009
Product
ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-06-80-120. In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.
Codes / lots: lot # 6691348
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.
FDA-determined cause: Labeling mix-ups
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".
Details
- Recall number
- Z-2024-2009
- Initiated
- June 10, 2009
- Posted by FDA
- September 8, 2009
- Terminated
- December 11, 2011
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Quantity
- 2
- Distribution
- International Distribution Only -- Brazil, Uruguay, & Malaysia.
- Recalling firm
- Ev3, Inc., Plymouth, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2022-2009 | ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent…ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System… | 06/10/2009Terminated |
| Z-2023-2009 | ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent…ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System… | 06/10/2009Terminated |
| Z-2025-2009 | ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent…ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System… | 06/10/2009Terminated |