FDA Recalls Axium Detachable Coil Systems for Incorrect Labeling
Micro Therapeutics is recalling Axium Detachable Coil Systems due to incorrect size and configuration labeling. The 96 affected units were distributed to China and the Republic of Korea.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an FDA Class II recall of a medical device due to labeling errors that could result in incorrect device selection. No illnesses or injuries have been reported, but the product presents a risk of harm due to potential device misselection based on incorrect size and configuration information.
Plain-English summary
Micro Therapeutics, Inc. is recalling the Axium Detachable Coil System (models QC-4-12-HELIX and QC-10-30-3D) due to incorrect size and configuration labeling on the affected units. The labeling errors may result in selection of an incorrectly sized or configured device for patient treatment.
A total of 96 systems with lot numbers B240079 and B240084 were affected. These devices were distributed internationally to China and the Republic of Korea.
Healthcare providers and facilities that received these devices should immediately discontinue use and contact Micro Therapeutics for replacement products with correct labeling. Patients treated with these devices should consult with their healthcare provider if they have concerns.
The recalled product
- Product
- AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
- Manufacturer
- Micro Therapeutics, Inc.
- Affected units
- 96
Distribution
Distribution scope not specified by the agency.
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