| Date Initiated by Firm | January 16, 2025 |
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| Date Posted | February 26, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1235-2025 |
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| Recall Event ID |
96175 |
| 510(K)Number | K223560 |
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| Product Classification |
Catheter, Percutaneous, Neurovasculature - Product Code QJP
|
| 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. |
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| Code Information |
Catalog Number: PL17-160-090
UDI-DI code: 00818075010479
Lot Number: 031300 |
| FEI Number |
3009546466
|
Recalling Firm/
Manufacturer |
Scientia Vascular, Inc.
2460 S 3270 W
West Valley City UT 84119-1116
|
| For Additional Information Contact | Mr. Larry Myres
760-899-4649 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On 01/02/2025, the firm email an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that through internal evaluation of finished goods of the Plato 17 Microcatheter, one lot of pouches containing the 90 Tip Plato 17 Microcatheter was identified with pouches that had a gap in the sterile barrier seal.
Customer are instructed to:
In situations where a device has already been used in a patient procedure, closely monitor patients for signs and symptoms of post-surgical infection.
Customer Service will be available to provide additional information and provide replacement orders at customercare@scientiavascular.com or (888)385-9016; Monday through Friday, 8:00 AM to 4:30 PM, Mountain Time. |
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| Quantity in Commerce | 1 unit |
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| Distribution | U.S. Nationwide distribution in the state of DE. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = QJP
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