| 2026-06-10 |
Class I
|
Ongoing |
Z-2680-2026 |
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F.… |
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Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub sco… |
| 2026-06-10 |
Class I
|
Ongoing |
Z-2679-2026 |
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F,… |
— |
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub sco… |
| 2026-06-10 |
Class I
|
Ongoing |
Z-2678-2026 |
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F … |
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Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub sco… |
| 2021-12-22 |
Class II
|
Completed |
Z-0646-2022 |
Destino Twist 14F (also branded as Guidestar 14F) |
— |
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. |
| 2021-03-10 |
Class II
|
Terminated |
Z-1329-2021 |
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various type… |
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Potential for open seal on sterile product |