AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Summary
The FDA issued a Class II for AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System by Micro Therapeutics, Inc.. Reason: Due to incorrect size and configuration labeling of the detachable coil system..
Details
Source
Device Recall
External ID
Z-1261-2022
Action Date
2022-06-22
Status
Ongoing
Category
device
Product Description
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Lot/Code Info: Product Number: QC-4-12-HELIX UDI-DI (GTIN) Code: 00847536029590 Lot Number: B240079 Product Number: QC-10-30-3D UDI-DI (GTIN) Code: 00847536030138 Lot Number: B240084
Quantity Affected: 96 systems
Reason for Recall
Due to incorrect size and configuration labeling of the detachable coil system.
Distribution
International distribution in the countries of China and Republic of Korea.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-27
Company
Irvine, 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 108 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Micro Therapeutics, Inc. has 9 FDA actions in our database, including 9 recalls.
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 (Micro Therapeutics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Micro Therapeutics, Inc. have FDA actions?
Micro Therapeutics, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1261-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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