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CrossCath

COOK INCORPORATED · Model G51580 · UDI-DI 00827002515802

KRA Prescription
10
510(k) clearances
9,137
Adverse events (366 deaths)
137
Recalls
150
Facilities

Description

CrossCath Support Catheter

Recalls

DateFirmReason
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16Boston Scientific Cork, Ltd.The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge

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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.