Scientia Vascular recalls Plato 17 Microcatheter REF PL17-160-090 due to potential packaging seal breaches that could compromise sterility during medical procedures.
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Scientia Vascular is recalling its Plato 17 Microcatheter (REF PL17-160-090) because manufacturing issues may cause gaps in the packaging seal. This could allow contamination during medical procedures, making the device unsafe for use.
The packaging seal may have channels due to manufacturing defects. This could create a breach in the sterile barrier, potentially allowing contamination during medical procedures.
Healthcare professionals using this microcatheter for medical procedures are affected. Patients receiving procedures with this device may be at risk if the packaging seal is compromised.
Check for the product name 'Plato 17 Microcatheter' and reference number PL17-160-090. This device was sold with lot number 031300.
Inspect the packaging pouch for channels in the seal, which may indicate manufacturing defects.
The recall states that the packaging seal may have channels due to manufacturing defects, which could compromise sterility. The device is not safe to use until the issue is addressed.
The recall does not specify a remedy, so you should check the packaging seal for channels and contact the manufacturer if you have concerns.
Look for the product name 'Plato 17 Microcatheter' and reference number PL17-160-090, which was sold with lot number 031300.
We’ve drafted a message you can send Scientia Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1235-2025 — Scientia Vascular Scientia Vascular Hello, I own a Scientia Vascular that is covered by recall Z-1235-2025 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.
