Scientia Vascular recalls Plato 17 Microcatheters with possible loose particles that could cause embolic events. Affected models include Straight Tip, 45-degree Tip, and 90-degree Tip variants. Check your product's lot numbers 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.
Scientia Vascular is recalling its Plato 17 Microcatheters due to potential loose particles inside the catheters that could cause blockages or inflammation in blood vessels. This risk applies to specific models and lot numbers sold between 2022 and 2023.
The microcatheters may contain loose particles that can be introduced into the bloodstream during procedures. This could lead to blockages in small blood vessels, inflammation, or embolic events where particles travel to critical areas of the body.
Medical professionals using the Plato 17 Microcatheters for vascular procedures are most at risk. Patients who have received these catheters may also be affected if particles were introduced during treatment.
Check the product label for model numbers: Straight Tip (PL17-160-000), 45-degree Tip (PL17-160-045), or 90-degree Tip (PL17-160-090). The recall includes specific lot numbers with expiration dates from August 2022 through March 2023.
Look for model numbers on the catheter: Straight Tip (PL17-160-000), 45-degree Tip (PL17-160-045), or 90-degree Tip (PL17-160-090).
Reach out to Scientific Vascular directly to confirm if your specific lot number is affected and to get instructions for next steps.
The recall includes Plato 17 Microcatheters with Straight Tip (PL17-160-000), 45-degree Tip (PL17-160-045), and 90-degree Tip (PL17-160-090) models.
Check the product label for the model number and compare it to the listed models (PL17-160-000, PL17-160-045, or PL17-160-090). Also, verify the lot number against the provided list of affected lots with expiration dates from August 2022 through March 2023.
Contact Scientific Vascular directly to confirm if your specific lot number is affected and to get instructions for next steps. The recall does not include a specific remedy like returning or discarding the product.
We’ve drafted a message you can send Scientia Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1249-2023 — Scientia Vascular Scientia Vascular Hello, I own a Scientia Vascular that is covered by recall Z-1249-2023 from Scientia Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.