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VECTRA®, VASCULAR ACCESS GRAFT

Thoratec Corporation · Model 10002-5040-001 · UDI-DI 00813024011323

DYF Prescription
10
510(k) clearances
196
Adverse events (6 deaths)
17
Recalls
8
Facilities

Recalls

DateFirmReason
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints 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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Data 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.