Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
Reported: March 22, 2023 Initiated: February 1, 2023 #Z-1249-2023
Product Description
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.
Details
- Recalling Firm
- Scientia Vascular, Inc.
- Units Affected
- 353
- 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.
- Location
- West Valley City, UT
Frequently Asked Questions
What product was recalled? ▼
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090. Recalled by Scientia Vascular, Inc.. Units affected: 353.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2023. Severity: Moderate. Recall number: Z-1249-2023.
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