Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On
Summary
The FDA issued a Class II for Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coati by MICROVENTION INC.. Reason: Sterility assurance; microcatheter inner packaging may contain incomplete seal..
Details
Source
Device Recall
External ID
Z-0990-2025
Action Date
2025-01-29
Status
Ongoing
Category
device
Product Description
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Lot/Code Info: Lot # 0000629846/UDI: (01)00816777027634
Quantity Affected: 107 units
Reason for Recall
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Distribution
US: None OUS: China
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-02
Company
Aliso Viejo, CA
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 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 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 (MICROVENTION INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MICROVENTION INC. have FDA actions?
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0990-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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