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MAXIFLO™
VASCUTEK LTD · Model T7005P · UDI-DI 05037881152257
DYF
Prescription
10
510(k) clearances
193
Adverse events (6 deaths)
17
Recalls
8
Facilities
Description
MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE SUPPORT.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
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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.