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DuraSheath Introducer Sheath System
Contract Medical International GmbH · Model 7F, 90cm, straigth · UDI-DI 04251244500306
DYB
Prescription
10
510(k) clearances
41,188
Adverse events (1,361 deaths)
389
Recalls
273
Facilities
Description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
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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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.