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ProCatid Delivery Catheter

GARDIA MEDICAL LTD · Model P2-9-0701 · UDI-DI 07290015512022

NTE Prescription

510(k) clearances

5,357

Adverse events (113 deaths)

Recalls

Facilities

Description

The ProCatid Delivery Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Delivery Catheter: Contains and delivers a Filter Unit, locks it onto the guide wire using the Activating Handle and deploys it in the target vessel. The Filter Unit is made of a filter membrane and a Nitinol frame. A 5cc syringe with a soft needle is supplied for flushing the system prior to use.

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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Data 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.