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ProCatid System kit Finished Good P2-9-0705-SRecalls & reported problems

Gardia Medical Ltd · 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 · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290015512015), received between Aug 22, 2018 and Aug 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Transient Ischemic Attack1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 22, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    A CAROTID PROCEDURE WAS CONDUCTED ON A (B)(6) YEAR OLD MALE. THE FILTER WAS SUCCESSFULLY PLACED IN THE INTERNAL CAROTID ARTERY WITH NO ISSUES. THE CAROTID PROCEDURE WAS COMPLETED WITH NO EVENTS. ONCE TRYING TO RETRIEVE THE FILTER, IT WOULD NOT COLLAPSE. NO VISIBLE OBSTRUCTION OR TORTUOUS ANATOMY WAS OBSERVED. THE PHYSICIAN APPLIED HIGH FORCE IN ORDER TO RETRIEVE THE FILTER. EVENTUALLY IT WAS RETRIEVED AND IT WAS NOTED THAT THE TIP OF THE FILTER WAS MISSING AND IT WAS LOCATED LODGED IN THE DISTAL ICA. THE TIP WAS CAPTURED AND RETRIEVED SUCCESSFULLY.

    Patient problems: Transient Ischemic Attack

    MAUDE report 7804299 ↗

Other Temporary Carotid Catheter For Embolic Capture devices

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Sources and updates

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