ProCatid System kit Finished Good
GARDIA MEDICAL LTD · Model P2-9-0705-S · UDI-DI 07290015512015
Description
The ProCatid Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire. SYSTEM COMPONENTS: 1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-09 | Boston Scientific Corporation | Potential for arterial sheath tip separation or partial tip separation during use. |
| 2026-07-09 | Boston Scientific Corporation | Potential for arterial sheath tip separation or partial tip separation during use. |
| 2023-10-12 | Medtronic Inc | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA |
| 2023-10-12 | Medtronic Inc | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA |
| 2023-10-12 | Medtronic Inc | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA |
| 2023-03-24 | Cordis US Corp | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unpl |
| 2023-03-24 | Cordis US Corp | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unpl |
| 2023-03-24 | Cordis US Corp | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unpl |
| 2023-03-24 | Cordis US Corp | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unpl |
| 2023-03-24 | Cordis US Corp | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unpl |
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