Home › Device types › PRL
Iliac Covered Stent, Arterial
FDA product code PRL · Class 3 · Unknown
230
Registered devices
2,542
Adverse events
6
Recalls
0
510(k) clearances
Devices with this code
GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.LifeStream — CLEARSTREAM TECHNOLOGIES LIMITEDGORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.iCast covered stent system, 12mm x 61mm x 80cm — Atrium Medical CorporationLifeStream — CLEARSTREAM TECHNOLOGIES LIMITEDLifeStream — CLEARSTREAM TECHNOLOGIES LIMITEDGORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.LifeStream — CLEARSTREAM TECHNOLOGIES LIMITEDGORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.GORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.LifeStream — CLEARSTREAM TECHNOLOGIES LIMITEDGORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.iCast Covered Stent System, 10mmX38mmX80cm — Atrium Medical CorporationGORE VIABAHN VBX Balloon Expandable Endo — W. L. Gore & Associates, Inc.LifeStream — CLEARSTREAM TECHNOLOGIES LIMITEDLifeStream — CLEARSTREAM TECHNOLOGIES LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-09 | Atrium Medical Corporation | There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. |
| 2024-07-01 | W L Gore & Associates, Inc. | Due to packaging defects, sterility assurance and heparin activity may be compromised. |
| 2024-07-01 | W L Gore & Associates, Inc. | Due to packaging defects, sterility assurance and heparin activity may be compromised. |
| 2023-09-21 | Atrium Medical Corporation | Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. |
| 2021-09-07 | W L Gore & Associates, Inc. | Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device. |
| 2019-02-18 | Bard Peripheral Vascular Inc | Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected ba |
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