| 2025-09-25 |
Class I
|
Ongoing |
Z-0188-2026 |
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09… |
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Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. |
| 2025-05-08 |
Class II
|
Ongoing |
Z-1989-2025 |
Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00… |
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Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
| 2025-05-08 |
Class II
|
Ongoing |
Z-1988-2025 |
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 0081006856885… |
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Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
| 2024-01-03 |
Class II
|
Ongoing |
Z-1042-2024 |
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices … |
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Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-1041-2024 |
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vascu… |
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Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified… |
| 2022-09-07 |
Class II
|
Ongoing |
Z-0103-2023 |
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures. |
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Product pouch label does not match up with carton label |
| 2022-07-26 |
Class II
|
Ongoing |
Z-1680-2022 |
Optima Coil System Model OPTI0520CSF10. For endovascular embolization. |
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Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. |
| 2022-01-04 |
Class II
|
Ongoing |
Z-0660-2022 |
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a… |
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Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result… |