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FlexCath Cross™ Transseptal Solution

MEDTRONIC, INC. · Model 900309 · UDI-DI 00763000925161

DYB DRE Prescription

510(k) clearances

40,654

Adverse events (1,345 deaths)

389

Recalls

273

Facilities

Description

NDL 900309 FLEXCATH CROSS SL 81CM EIFU

Recalls

Date	Firm	Reason
2026-06-15	Terumo Medical Corporation	Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
2026-06-11	Abiomed, Inc.	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua
2026-06-11	Abiomed, Inc.	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua
2026-06-11	Abiomed, Inc.	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua
2026-06-11	Abiomed, Inc.	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua
2026-06-11	Abiomed, Inc.	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua
2026-06-11	Abiomed, Inc.	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua
2026-06-11	Abiomed, Inc.	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua
2026-06-11	Abiomed, Inc.	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua
2026-06-11	Abiomed, Inc.	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua

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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.