Home › Atrium Medical Corporation › iCast Covered Stent System, 5mmX22mmX120cm
iCast Covered Stent System, 5mmX22mmX120cm
Atrium Medical Corporation · Model 42522 · UDI-DI 00650862425222
PRL
Prescription
0
510(k) clearances
2,542
Adverse events (73 deaths)
6
Recalls
12
Facilities
Description
iCast Covered Stent System, 5mmX22mmX120cm
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 balloon expandable vas |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.