# FDA recall Z-1249-2023

> **Scientia Vascular, Inc.** · Class II · device recall initiated 2023-02-01.

## Product

Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090

## Reason for recall

Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to placement, may have loose particles within catheter lumens that may be introduced to patients, which could cause embolic event, small vessel occlusion, and subacute to chronic inflammatory response.

## Distribution

US Nationwide distribution in the states of IL, AL, FL, NC, WI, GA, SC, IN, KS, CA, OH, NY, NH, CO, MA, NV, UT, TX.

## Key facts

- **Recall number:** Z-1249-2023
- **Recalling firm:** Scientia Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-01
- **Report date:** 2023-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Valley City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1249-2023

## Citation

> AI Analytics. FDA recall Z-1249-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1249-2023. Source: US FDA. Licensed CC0.

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