Class II Recall

Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090

Summary

The FDA issued a Class II for Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045 by Scientia Vascular, Inc.. Reason: Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to fl.

Details

Source

Device Recall

External ID

Z-1249-2023

Action Date

2023-03-22

Status

Ongoing

Product Description

Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090

Lot/Code Info: All lots, REF/UDI-DI/Lot(Expiration): PL17-160-000/00818075010455/ 900164(8/31/2022), 900165(8/31/2022), 900172(8/31/2022), 900177(9/30/2022), 900180(9/30/2022), 900186(10/31/2022), 900187(10/31/2022), 900188(10/31/2022), 900193(10/31/2022), 900196(12/31/2022), 900199(12/31/2022), 900202(12/31/2022), 900221(2/28/2023), 900222(2/28/2023), 900225(2/28/2023), 900226(3/31/2023), 20441(11/30/2023), 20476(11/30/2023), 20650(12/31/2023); PL17-160-045/00818075010462/900167(8/31/2022), 900168(8/31/2022), 900169(8/31/2022), 900174(8/31/2022), 900175(8/31/2022), 900179(9/30/2022), 900181(9/30/2022), 900183(10/31/2022), 900185(10/31/2022), 900205(1/31/2023), 900206(1/31/2023), 900210(1/31/2023), 900211(1/31/2023), 900215(1/31/2023), 900220(1/31/2023), 900219(1/31/2023), 900217(2/28/2023), 900223(2/28/2023), 900224(2/28/2023); PL17-160-090/00818075010479/900170(8/31/2022), 900171(8/31/2022), 900178(9/30/2022), 900182(9/30/2022), 900184(10/31/2022), 900192(11/30/2022), 900195(11/30/2022), 900209(1/31/2023), 900228(3/31/2023)

Quantity Affected: 353

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.

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-01

Company

Scientia Vascular, Inc.

West Valley City, UT

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Scientia Vascular, Inc. has 9 FDA actions in our database, including 3 recalls and 6 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Scientia Vascular, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Scientia Vascular, Inc. have FDA actions?

Scientia Vascular, Inc. has 9 FDA actions in our database, including 3 recalls and 6 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1249-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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