Home › Baylis Médicale Cie Inc › ExpanSure Large Access Transseptal Dilator
ExpanSure Large Access Transseptal Dilator
Baylis Médicale Cie Inc · Model ESD125-35-85-70-N · UDI-DI 00685447004707
10
510(k) clearances
3,180
Adverse events (186 deaths)
40
Recalls
97
Facilities
Description
One transseptal dilator; one J-tip guidewire.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2025-03-27 | Galt Medical Corporation | Due to a potential open seal in the sterile barrier packaging . |
| 2024-08-12 | Merit Medical Systems, Inc. | 7F sheath introducers labeled as 7.5F |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due |
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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.