Plato 17 Microcatheter Recall Due to Sterile Barrier Packaging Defect
Scientia Vascular is recalling Plato 17 Microcatheter units due to manufacturing defects in the packaging seal that could compromise sterility during vascular procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a medical device recall with a potential sterile barrier compromise on a vascular catheter used in invasive procedures. This represents a risk of harm to patients. No injuries or illnesses have been reported, which per the rubric limits the score to 3 (High) for risk-of-harm products without documented injury.
Plain-English summary
Scientia Vascular, Inc. is recalling Plato 17 Microcatheter (Catalog Number PL17-160-090, Lot 031300) due to a manufacturing defect in the packaging.
During manufacturing, channels formed in the seal of the packaging pouch. This defect could potentially create a breach in the sterile barrier, which is critical to maintaining the device's sterility.
The Plato 17 Microcatheter is used to deliver therapeutic devices, embolization materials, and diagnostic agents into the neuro and peripheral vasculature during interventional and diagnostic procedures. A sterile barrier breach could allow contamination of the device before clinical use.
Healthcare providers and patients who have these units should contact Scientia Vascular, Inc. immediately for guidance on handling, storage, and replacement of affected products.
The recalled product
- Product
- Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
- Manufacturer
- Scientia Vascular, Inc.
- Hazard
- sterile-barrier-breach
- contamination-risk
- packaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
Distribution
Distributed nationwide across the United States.
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